Orthopedic and implantable devices
From concept to clearance to market access and adoption
CAHIR AI pairs AI-powered regulatory and market intelligence with a business partner who has spent more than 14 years designing, testing and clearing hip, knee, ankle and revision implants through FDA 510(k).
- 14+
- Years in orthopedic implant R&D and regulatory (2012–present)
- 28
- FDA 510(k) clearances listed in the partner's history
- 6
- US orthopedic patents and design patents
- 25+
- Years of medical device and mechanical engineering experience
Business partner past performance
Our orthopedic business partner, founder of Arthroplasty Regulatory Consulting, LLC (2023–present), led regulatory and validation strategy as Director of Research and Development at Total Joint Orthopedics (2012–2023), serving as 510(k) project lead and primary FDA contact. Recent work includes three clearances as an independent consultant, and FDA 510(k) Third Party Reviewer training completed in August 2026.
- • 510(k) authoring and eSTAR submission, plus FDA correspondence and deficiency responses
- • Material characterization: vitamin E and crosslinked UHMWPE, porous ingrowth and ceramic coatings
- • Testing: strength, component and construct fatigue, dissociation, simulator wear, fretting and corrosion, contact stress, constraint, impingement
- • Porous coating ovine ingrowth studies (published research)
- • Cleaning, packaging and gamma/EO sterilization validation; labeling and product registration
- • Implant and instrument design, including novel coating technology (IBED TiN) presented at ISTA 2019–2024
Implantable Device Development and 510(k) Strategy
Design controls and risk
Design inputs, verification and validation under FDA's QMSR (aligned with ISO 13485) and ISO 14971 risk management, built for a predicate-driven submission from day one.
Predicate and test strategy
Pick predicates that minimize new testing, map applicable ASTM and ISO standards, and plan bench, wear and biocompatibility work before tooling is cut.
Submission and FDA interaction
Compile the eSTAR, use a Q-Submission where risk is high, and consider the Third Party Review Program for eligible devices.
MedTech Copilot speeds this phase: standards mapping, testing outlines and submission drafting in one AI workspace. Launch MedTech Copilot · FDA regulatory pathways guide
Clearance-to-Adoption Strategy for Orthopedic Devices
A cleared implant still has to win hospital value analysis committees, surgeon preference and payer economics. We plan the adoption path alongside the regulatory one.
Value analysis committee dossier
Clinical evidence, total cost of ownership and instrument-set logistics packaged the way hospital supply chain teams review them.
Inpatient, outpatient and ASC economics
Joint replacement is moving to outpatient and ambulatory surgery settings; model implant cost against CMS outpatient payment and inpatient DRG reimbursement.
Evidence and registries
Plan post-market data through the American Joint Replacement Registry to support survivorship claims and contracting.
Market scoring and competitors
Score target markets, competing systems and payer exposure before committing a commercial launch budget.
Cleared product history
Each number links to its FDA 510(k) database record. Years are inferred from the K-number.
| 510(k) | Device | Area | Year |
|---|---|---|---|
| K140942 | Klassic Knee Tibial Stem Extension | Knee | 2014 |
| K141972 | Klassic HD Hip System – Insert with E-Link Poly | Hip | 2014 |
| K143113 | Klassic BiPolar System – BiPolar Femoral Heads, 22mm | Hip | 2014 |
| K143407 | Klassic HD Hip System – Biolox delta Ceramic Femoral Heads, 12/14 Taper | Hip | 2014 |
| K150105 | Klassic Knee Sombrero Patella | Knee | 2015 |
| K151440 | Klassic Blade Femoral Stems | Hip | 2015 |
| K153075 | Klassic Knee System – CR/Congruent Tibial Insert (18mm) | Knee | 2015 |
| K153310 | Klassic Knee System – Femur, Size 7 | Knee | 2015 |
| K161073 | Klassic HD Hip System – Acetabular Insert with XLPE | Hip | 2016 |
| K162256 | Klassic Knee Femur with Cobalt 3D | Knee | 2016 |
| K162422 | Klassic Knee All-Poly Tibia CR/Congruent | Knee | 2016 |
| K171962 | Klassic Blade Femoral Stems, Sizes 10–12 | Hip | 2017 |
| K173104 | Klassic HD Hooded Acetabular Insert with E-Link Poly | Hip | 2017 |
| K180159 | Klassic Knee System – CR/Congruent Tibial Insert with E-Link | Knee | 2018 |
| K180929 | Klassic HD Hip System – Biolox delta Ceramic Femoral Heads (22 and 28mm) | Hip | 2018 |
| K183596 | Klassic PS-Post Femur | Knee | 2018 |
| K190280 | Klassic Sombrero Patella with E-Link Poly – Size 5, 10mm | Knee | 2019 |
| K191399 | 28mm BIOLOX CONTOURA Ceramic Femoral Head, 12/14 Taper, -3.5mm | Hip | 2019 |
| K202740 | Klassic Knee System Tibial Insert, PS-Max | Knee | 2020 |
| K211602 | Klassic Femur with Aurum | Knee | 2021 |
| K211877 | Klassic Knee CR/Congruent and Ultra-PS Tibial Inserts with E^X Poly | Knee | 2021 |
| K213580 | Klassic HD Hip System – Adapters for Biolox Option Ceramic Heads | Hip | 2021 |
| K220483 | Platform Cup with Ti-Coat | Hip | 2022 |
| K230537 | Klassic Stem Extension, Femoral, Cemented | Knee | 2023 |
| K232414 | Klassic Knee PS-Post All-Poly Tibia and Thicker PS-Post Inserts | Knee | 2023 |
| K240475 | Hintermann Series H2 Total Ankle System | Ankle | 2024 |
| K243991 | Klassic Knee System – Revision Tibial Baseplate | Revision / Spacer | 2024 |
| K261734 | Klassic Infection Spacer System | Revision / Spacer | 2026 |
Planning an orthopedic or implantable device?
Talk to us about predicate strategy, testing, submission and the path to hospital adoption.
Sources
- FDA – Premarket Notification 510(k)
- FDA – 510(k) Third Party Review Program
- FDA – Voluntary eSTAR Program
- FDA – Quality Management System Regulation (QMSR)
- FDA – 510(k) Premarket Notification database
- American Joint Replacement Registry (AAOS)
- CMS – Hospital Outpatient PPS
- Epperson et al., J Biomed Mater Res B, 2020 (PMID 31696659)