Howmedica Osteonics Corp.: FDA clearances and approvals
Howmedica Osteonics Corp. has 301 FDA 510(k) clearances (first 1999, latest 2020), plus 2 PMA decisions, across 48 product codes in 3 review panels. Median 510(k) review time: 57 days. openFDA lists 247 product recalls by a recalling firm named Howmedica Osteonics Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 90 |
| 2013 | 5 | 227 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 148 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Howmedica Osteonics Corp.'s cleared 510(k)s took a median 148 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 39 | 39 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 32 | 32 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 24 | 24 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 19 | 19 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 19 | 19 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 17 | 17 |
| HRS | Plate, Fixation, Bone | 16 | 16 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 16 | 16 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 10 | 10 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 9 | 9 |
Plus 38 more product codes.
Review panels
- Orthopedic (300)
- General and Plastic Surgery (2)
- Neurology (1)
Most recent Howmedica Osteonics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | JDI | 2020-08-13 | 247 |
| K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite | MBH | 2020-05-13 | 48 |
| K130895 | REUNION RSA SHOULDER SYSTEM | PHX | 2013-12-27 | 270 |
| K123604 | ABG III MONOLITHIC HIP STEM | MAY | 2013-08-16 | 268 |
| K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE | KRO | 2013-02-22 | 227 |
| K123166 | TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P | JWH | 2013-02-14 | 128 |
| K122853 | NOVEL FIT AND FILL STEM | MEH | 2013-02-01 | 136 |
| K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | FWP | 2012-11-01 | 183 |
| K121308 | HIP SYSTEMS | LPH | 2012-07-30 | 90 |
| K120578 | ACCOLADE II HIP STEM | JDI | 2012-03-29 | 31 |
291 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P000013 | PMA | TRIDENT SYSTEM | 2003-02-03 |
| P960047 | PMA | OSTEONICS CONSTRAINED ACETABULAR INSERT | 1997-06-13 |
Recalls
247 product recalls in 50 recall events; 124 initiated in the last five years. Most recent: 2026-07-30.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Howmedica Osteonics Corp. have?
Howmedica Osteonics Corp. has 301 FDA 510(k) clearances (first 1999, latest 2020), plus 2 PMA decisions, across 48 product codes in 3 review panels.
How long does FDA take to clear Howmedica Osteonics Corp.'s 510(k)s?
The median time from FDA receipt to decision across Howmedica Osteonics Corp.'s cleared 510(k)s is 57 days.
What devices does Howmedica Osteonics Corp. make?
Its most frequent FDA product codes are HSB (Rod, Fixation, Intramedullary And Accessories, 39); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 32); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 24).
Has Howmedica Osteonics Corp. had device recalls?
openFDA lists 247 product recalls in 50 recall events by a recalling firm whose name matches Howmedica Osteonics Corp; the most recent began 2026-07-30. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 301 Howmedica Osteonics Corp. clearances with predicates and recalls
- Run predicate analysis for product code HSB, Howmedica Osteonics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.