Kirschner Medical Corp.: FDA clearances and approvals
Kirschner Medical Corp. has 76 FDA 510(k) clearances (first 1983, latest 1995), across 32 product codes in 5 review panels. Median 510(k) review time: 86 days.
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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 17 | 17 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 9 | 9 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 4 | 4 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 4 | 4 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 3 | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 3 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 3 | 3 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 | 3 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 2 | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 2 | 2 |
Plus 22 more product codes.
Review panels
- Orthopedic (66)
- General and Plastic Surgery (2)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Kirschner Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940537 | KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM | KWT | 1995-08-29 | 568 |
| K936274 | KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM | JWH | 1995-01-18 | 384 |
| K942891 | SUMMIT TOTAL HIP SYSTEM | MEH | 1994-11-02 | 135 |
| K941486 | INTEGRITY TOTAL HIP SYSTEM, NON-POROUS | JDI | 1994-09-20 | 176 |
| K933843 | LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED | JWH | 1994-08-05 | 364 |
| K935951 | KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM | JDI | 1994-07-18 | 217 |
| K935206 | KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION | JDI | 1994-07-13 | 257 |
| K934589 | KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED | JWH | 1994-07-13 | 292 |
| K934694 | KIRSCHNER ZIRCONIA FEMORAL HEAD | LZO | 1994-05-18 | 230 |
| K920188 | THREADED PINS | MBJ | 1993-05-12 | 483 |
66 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kirschner Medical Corp..
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 Kirschner Medical Corp. have?
Kirschner Medical Corp. has 76 FDA 510(k) clearances (first 1983, latest 1995), across 32 product codes in 5 review panels.
How long does FDA take to clear Kirschner Medical Corp.'s 510(k)s?
The median time from FDA receipt to decision across Kirschner Medical Corp.'s cleared 510(k)s is 86 days.
What devices does Kirschner Medical Corp. make?
Its most frequent FDA product codes are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 17); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 9); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 4).
Has Kirschner Medical Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kirschner Medical Corp. Related entities may recall under other names.
Next steps
- See all 76 Kirschner Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Kirschner Medical 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.