Medical Device Companies
174K 510(k) clearances cross-referenced with device recalls, hospital procedure volumes, and surgeon-level data for commercial targeting.
How it works
These are real reports generated from live FDA, CMS, and Medicare data. Ask Medistill to analyze the competitive landscape for your device, it pulls surgeon volumes, 510(k) clearances, recall histories, and market opportunities in one conversation.
Query
“We're launching a new hip implant in the Southeast. Who are the top 20 orthopedic surgeons by total hip arthroplasty volume? And what competing devices have active 510(k) clearances?”
| Rank | Surgeon | City | State | Hospital | Volume | Avg Payment |
|---|---|---|---|---|---|---|
| 1 | Edward Stolarski, MD | Sarasota | FL | Kennedy White & Riggs Orthopaedic | 297 | $1,059 |
| 2 | Charles DeCook, MD | Cumming | GA | Advanced Joint Surgery Specialists | 182 | $1,027 |
| 3 | Henry Biggs, D.O. | Naples | FL | Joint Replacement Institute | 179 | $1,130 |
| 4 | John McCrosson, MD | Mt Pleasant | SC | Roper Saint Francis Physicians Network | 168 | $978 |
| 5 | Jonathan Courtney, MD | Deerfield Beach | FL | Orthopaedic Surgery Associates PA | 164 | $1,143 |
| 6 | Joseph Locker, M.D. | Ocala | FL | The Orthopaedic Institute PA | 157 | $1,062 |
| 7 | Elvis Grandic, MD | Boynton Beach | FL | Orthopaedic Surgery Associates PA | 156 | $1,131 |
| 8 | Justin Brothers, M.D. | Myrtle Beach | SC | OrthoSC LLC | 141 | $964 |
| 9 | Edward Humbert, DO | Fort Myers | FL | Joint Implant Surgeons of Florida PA | 138 | $1,139 |
| 10 | John Redmond, MD | Jacksonville | FL | North Florida Surgeons PA | 134 | $1,057 |
| 11 | John Wang, M.D. | West Palm Beach | FL | HSS Florida Physicians LLC | 132 | $1,139 |
| 12 | Matthew Mai, M.D. | Fort Walton Beach | FL | North Florida Surgeons PA | 131 | $1,047 |
| 13 | William Ballard, M.D. | Chattanooga | TN | Chattanooga Orthopaedic Group PC | 128 | $910 |
| 14 | Howard Homesley, MD | Charlotte | NC | NC Orthopaedic Clinic | 123 | $998 |
| 15 | Gregory Martin, M.D. | Boynton Beach | FL | Preferred Orthopedics of the Palm Beaches | 123 | $1,122 |
| 16 | Sean Dingle, MD | Sarasota | FL | Kennedy White & Riggs Orthopaedic | 121 | $1,052 |
| 17 | James Loging, M.D. | Clinton | SC | Palmetto Bone and Joint | 117 | $961 |
| 18 | Charles Hope, MD | Savannah | GA | Optim Orthopedics LLC | 115 | $970 |
| 19 | Scott Miller, MD | Melbourne | FL | Health First Medical Group | 115 | $1,057 |
| 20 | Scott Kelley, MD | Durham | NC | North Carolina Orthopaedic Clinic | 114 | $974 |
VELYS Hip Navigation
NavigationDePuy (J&J) · K253551
Image-free surgical navigation system for THA
Cleared: Mar 2026
G7 Revision Acetabular System
Cup/shellZimmer Biomet · K252623
Modular revision acetabular shell with trabecular metal
Cleared: Feb 2026
Libertas TS Uncemented Femoral Stem
Femoral stemMaxx Orthopedics · K253171
Short taper femoral stem for cementless primary THA
Cleared: Jan 2026
NextAR Hip Platform
NavigationMedacta · K252847
AR-assisted navigation platform for hip reconstruction
Cleared: Jan 2026
Velora Acetabular System
Cup/shellRestor3D · K252067
3D-printed porous acetabular shell
Cleared: Dec 2025
TaperSet Hip System
Femoral stemConsensus Orthopedics · K252846
Cementless tapered femoral stem system
Cleared: Nov 2025
EMPOWR Acetabular Liner Extension
Cup/shellEncore Medical · K251833
Modular acetabular liner with extension options
Cleared: Nov 2025
Allure Hip Stem and IM Plugs
Femoral stemWaldemar Link · K250375
Hydroxyapatite-coated cementless stem with IM plugs
Cleared: Nov 2025
OTS Hip
NavigationOrtoma AB · K250086
CT-based surgical planning and navigation for THA
Cleared: May 2025
Trabecular Metal Acetabular Revision System
Cup/shellZimmer Biomet · K243571
Porous trabecular metal shells/liners for revision
Cleared: Jul 2025
Stryker/Serf hip devices
Femoral stemStryker Orthopaedics · K250989
Expanded device family including cemented stems
Cleared: Jul 2025
Z1 Hip System
Femoral stemZimmer Biomet · K251906
Short-stem uncemented femoral component
Cleared: Jul 2025
Mfinity Femoral System
Femoral stemMedacta · K251166
Modular cementless femoral stem platform
Cleared: Jun 2025
ONVOY Acetabular System
Cup/shellGlobus Medical · K243456
Porous titanium acetabular shell system
Cleared: Jun 2025
Trinity EVO Acetabular Shell
Cup/shellCorin USA · K242744
Hydroxyapatite-coated cementless acetabular cup
Cleared: Jun 2025
RECLAIM Monobloc Revision Femoral Stem
Femoral stemDePuy (J&J) · K251292
Fully porous monobloc revision stem
Cleared: May 2025
Trivicta Hip Stem
Femoral stemOrtho Development · K251052
Tapered wedge cementless primary femoral stem
Cleared: May 2025
Coated hip implants
Femoral stemMedacta · K250450
Hydroxyapatite and calcium phosphate coated femoral stems
Cleared: Sep 2025
Follow-up query
“Now show the recall history for these competitors. Which companies have quality problems we can exploit?”
Zimmer Biomet
3 recalls
Dual Mobility Vivacit-E Bearing (2 lots)
Ceramic Femoral Head 22.2mm (5 SKUs)
Z1 Femoral Hip System, Offset Stem Inserter
Exactech
1 recall
Novation XLE, Alteon XLE, AcuMatch XLE acetabular liners
Encore Medical/Enovis
2 recalls
EMPOWR Acetabular System, hooded liners (4 SKUs)
EMPOWR Dual Mobility Poly Bearings ID28 OD40/42
MicroPort Orthopedics
2 recalls
HIPTURN Femoral Head Trial 36mm
PROFEMUR Plasma Z Classic Stem Size 7
Restor3D/Conformis
1 recall
Cordera Hip System acetabular liner GRP C 36mm lip
BioPro
1 recall
BioPro Femoral Heads, cobalt-chrome, ceramic, lightweight
Ortoma AB
1 recall
Ortoma Inserter Adapter OTD
Waldemar Link
1 recall
LINK MP Reconstruction System, Neck Segment XXL
Biomet legacy
1 recall
Arcos Modular Revision Hip System, Standard Cone Proximal Body Size A 60mm
Follow-up query
“Map the market opportunity by county. Where should we focus our sales team first?”
| County | State | Key Surgeons | Opportunity | Medicare Spend/Bene | THA Vol | MA % | Readmit % | Senior % | Risk Tags |
|---|---|---|---|---|---|---|---|---|---|
| Sarasota | FL | Stolarski, Dingle | High | $11,850 | 418 | 42% | 16.8% | 37% | SNF penalties >$300K |
| Collier | FL | Biggs, Zehr | High | $11,788 | 285 | 39% | 15.2% | 32% | – |
| Palm Beach | FL | Courtney, Grandic, Martin, Wang | Medium | $12,405 | 575 | 51% | 18.1% | 26% | High MA penetration |
| Forsyth | GA | DeCook | Medium | $9,870 | 182 | 34% | 15.9% | 14% | – |
| Charleston | SC | McCrosson | Medium | $10,120 | 168 | 31% | 16.4% | 16% | – |
| Knox | TN | – | Medium | $9,540 | 145 | 28% | 17.0% | 15% | – |
| Duval | FL | Redmond | Medium | $10,980 | 198 | 45% | 17.5% | 14% | – |
| Lee | FL | Humbert | Medium | $11,220 | 210 | 44% | 16.9% | 28% | – |
| Mecklenburg | NC | Homesley | Medium | $9,650 | 165 | 33% | 16.1% | 11% | – |
| Horry | SC | Brothers | Medium | $10,350 | 155 | 36% | 17.2% | 24% | – |
| Broward | FL | – | Lower | $13,200 | 320 | 68% | 21.2% | 18% | High MA 68%, high readmit, SNF penalties |
| Miami-Dade | FL | – | Lower | $17,605 | 290 | 79% | 21.8% | 16% | MA 79%, highest readmit, high spend |
| State | Total Fines | Facilities | Avg/Penalty |
|---|---|---|---|
| FL | $22.1M | 311 | $27K |
| NC | $18.9M | 256 | $32K |
| TN | $8.8M | 108 | $47K |
| GA | $6.3M | 145 | $22K |
| SC | $3.5M | 107 | $14K |
What you can ask
Each question runs against real data. Follow-ups build on previous results , Medistill remembers context across the entire conversation.
510(k) clearance pipeline, cardiovascular
“Show me every FDA 510(k) clearance for cardiovascular devices in the last 3 years. Which companies got the most clearances? What’s the trend, is the market accelerating or cooling?”
Queries the complete 510(k) database to surface clearance velocity and competitive dynamics, the intelligence that takes regulatory teams weeks to compile manually.
“For the top 5 companies by clearances, cross-reference with device enforcement recalls. Which companies have the highest clearance-to-recall ratio, clearing lots of devices but also getting lots recalled?”
Connects clearance data to recall data, reveals which competitors have quality problems that create market opportunity.
“Were any of the recalled devices expedited review? Is fast-tracking correlated with higher recall rates?”
Tests the hypothesis that expedited pathways produce more recalls, critical intelligence for regulatory strategy.
Without Medistill
Download FDA 510(k) database, separately download enforcement recalls, manually cross-reference by company and product code. Multi-week regulatory affairs project.
Hospital targeting, joint replacement
“We’re launching a new orthopedic implant. Identify the 50 hospitals with the highest volume of joint replacement procedures by Medicare billing. Show their city, state, total procedures, and quality scores.”
Combines Medicare utilization data with hospital quality scores to identify high-volume, high-quality targets, the hospital list your commercial team needs.
“For the top 20 hospitals, who are the orthopedic surgeons performing the most joint replacements? Show each surgeon’s volume, quality score, and whether they receive payments from our competitors.”
Maps individual surgeon relationships with competitors, identifies who’s locked up and who’s available.
“For surgeons receiving zero industry payments, these are our greenfield targets. Pull their contact info and practice details.”
Greenfield surgeons with high volume and no competitor relationships are the highest-ROI targets for your sales team.
Without Medistill
Request hospital procedure data from CMS, separately download industry payments, manually match surgeons to hospitals and competitor relationships. Months of commercial ops work.
Competitor recall intelligence
“Our competitor just had a Class I recall on their spinal device. Pull the full recall details, reason, distribution, classification. Then show every hospital that was likely using that device based on high spinal surgery volume.”
Turns a competitor’s quality failure into a targeting opportunity, maps affected hospitals in real time.
“For those hospitals, who are the top spine surgeons? They’ll need an alternative device, show their procedure volumes and current industry payment relationships.”
Identifies surgeons who are actively looking for alternatives due to the recall, time-sensitive competitive intelligence.
Without Medistill
Monitor FDA recall database manually, separately research hospital procedure volumes, manually identify affected surgeons. By the time you’ve done the research, competitors have already moved.
510(k) pipeline, ophthalmic
“Track the 510(k) clearance pipeline for ophthalmic devices. How many clearances per year over the last 5 years? Which advisory committees are busiest? Is this space growing?”
Tracks regulatory pipeline velocity by specialty, shows whether a market segment is accelerating or maturing.
“Which companies dominate ophthalmic device clearances? Show market share by applicant.”
Maps competitive concentration, identifies whether the market is consolidated or fragmented.
Without Medistill
Download FDA 510(k) database, filter by product codes, manually build year-over-year trend analysis. Days of regulatory affairs work.
Clearance time benchmarking
“Our regulatory team needs to benchmark our 510(k) clearance times. What’s the average time from submission to decision for orthopedic devices? How does it compare to cardiovascular or ophthalmic?”
Benchmarks your regulatory performance against industry averages by specialty, the data your team needs for board presentations.
“Are third-party-reviewed 510(k)s cleared faster than FDA-reviewed ones? Show the comparison by device category.”
Quantifies the third-party review pathway advantage, informs whether to pursue 3P review for upcoming submissions.
Without Medistill
Download full 510(k) database, calculate decision dates minus receipt dates, segment by product code, build statistical comparison. Multi-day analysis.
Why switch
510(k) tracking
510(k) tracking
Download FDA database, manually filter
174K+ clearances, searchable by company, product, date, advisory panel
Recall monitoring
Recall monitoring
Check FDA recalls weekly, manually match
38K+ recalls cross-referenced with hospital targeting and surgeon data
Hospital targeting
Hospital targeting
Request CMS data, build scorecards manually
6,100+ hospitals with quality scores, financials, and 6B+ negotiated rates
Surgeon identification
Surgeon identification
Separate CMS, industry-payment downloads
2.6M provider-facility links, find surgeons by procedure, volume, facility, and geography
Geographic targeting
Geographic targeting
Not available
Find surgeons within X miles by specialty. 99.8% geocoded. Filter by facility.
Competitive intelligence
Competitive intelligence
Multiple databases, manual cross-referencing
Competitor clearances, recalls, surgeon relationships, and pharma payments linked
Market share estimation
Market share estimation
Census + CMS utilization, weeks of analysis
% of procedures by hospital in any state, competitive positioning instantly
Compliance screening
Compliance screening
Not available
130+ federal + state sources, screen surgeons for exclusions, malpractice, board actions
Hospital price transparency
Hospital price transparency
Not available
6B+ negotiated rates from 6,100+ hospitals, see what payers pay for device-related procedures
Any language
Any language
English only
Ask and receive answers in any language
Price
Price
$100K–$500K/yr data subscriptions + FTEs
From $199/mo
Data coverage
FDA 510(k)
Device Recalls
Medicare Utilization
Hospital Quality
Industry payments
Price Transparency
Find Surgeons by Hospital & Procedure
Compliance & Enforcement
174K clearances, 38K recalls, 6B+ negotiated rates, 273K facilities, surgeon volumes , all queryable in one conversation at from $199/month. In any language.