Howmedica Corp.: FDA filings under this applicant name
FDA lists 409 510(k) clearances under 2 spellings of the applicant name “Howmedica Corp.” (first 1976, latest 1999), plus 3 PMA decisions, across 82 product codes in 11 review panels. Median 510(k) review time under this name: 77 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Stryker, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 47 | 47 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 43 | 43 |
| HRS | Plate, Fixation, Bone | 27 | 27 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 26 | 26 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 22 | 22 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 19 | 19 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 18 | 18 |
| JEC | Component, Traction, Invasive | 13 | 13 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 12 | 11 |
| HWC | Screw, Fixation, Bone | 12 | 12 |
Plus 72 more product codes.
Review panels
- Orthopedic (335)
- Dental (33)
- Gastroenterology and Urology (17)
- General and Plastic Surgery (7)
- Cardiovascular (5)
- General Hospital (4)
- Ear, Nose and Throat (1)
- Ophthalmic (1)
- Pathology (1)
- Physical Medicine (1)
- Radiology (1)
Most recent Howmedica Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984251 | XIA SPINE SYSTEM | KWQ | 1999-02-24 | 89 |
| K984202 | HOWMEDICA HUMERAL INTERCALARY SYSTEM | HSD | 1999-02-05 | 73 |
| K984305 | ZETA MULTIZONE LOCKING NAIL SYSTEM | HSB | 1999-02-01 | 61 |
| K983885 | BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES | JEY | 1999-01-29 | 88 |
| K983528 | MICRO DYNAMIC MESH | JEY | 1998-12-23 | 76 |
| K983404 | TYPE 3 FEMORAL COMPONENTS | LZO | 1998-12-22 | 85 |
| K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION | JDI | 1998-12-16 | 280 |
| K980925 | DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION | JWH | 1998-12-16 | 280 |
| K980632 | DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION | JWH | 1998-12-11 | 295 |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | JDI | 1998-12-11 | 296 |
399 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P840049 | PMA | P.C.A.(TM) TOTAL KNEE SYSTEM | 1988-09-30 |
| N17003 | PMA | SURGICAL SIMPLED P BONE CEMENT | 1971-10-07 |
| N17004 | PMA | SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENT | 1971-10-07 |
Recalls
openFDA lists no recalls under a recalling firm named Howmedica Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Howmedica Corp. (376)
- Howmedica, Inc. (36)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Howmedica Osteonics Corp. (301 510(k)s)
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics (33 510(k)s)
- Howmedica Leibinger, Inc. (11 510(k)s)
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (9 510(k)s)
- Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) (2 510(k)s)
- Howmedica Osteonics Corp. Dba Stryker Orthopeadics (1 510(k)s)
- Howmedica Osteonics, Dba Stryker Orthopaedics (1 510(k)s)
- Howmedica, Pfizer Medical Technology Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Howmedica Corp.?
FDA lists 409 510(k) clearances under 2 spellings of the applicant name “Howmedica Corp.” (first 1976, latest 1999), plus 3 PMA decisions, across 82 product codes in 11 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Howmedica Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Howmedica Corp. is 77 days.
Which FDA product codes appear under Howmedica Corp.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 47); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 43); HRS (Plate, Fixation, Bone, 27).
Next steps
- See all 409 Howmedica Corp. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Howmedica Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.