Total Joint Othopedics, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Total Joint Othopedics, Inc.” (first 2014, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 55 days. Since 2017 the median was 55 days, against 105 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 25 |
| 2015 | 0 | — |
| 2016 | 1 | 184 |
| 2017 | 1 | 24 |
| 2018 | 0 | — |
| 2019 | 1 | 96 |
| 2020 | 0 | — |
| 2021 | 1 | 23 |
| 2022 | 0 | — |
| 2023 | 2 | 55 |
| 2024 | 0 | — |
| 2025 | 1 | 88 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Total Joint Othopedics, Inc. took a median 55 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 | 3 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 3 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
Review panels
- Orthopedic (8)
Most recent Total Joint Othopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243991 | Klassic Knee System - Revision Tibial Baseplate | JWH | 2025-03-24 | 88 |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | JWH | 2023-09-08 | 29 |
| K230537 | Klassic Knee Revision System | JWH | 2023-05-19 | 81 |
| K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length | LZO | 2021-12-03 | 23 |
| K191399 | BIOLOX CONTOURA Ceramic Femoral Head | LZO | 2019-08-28 | 96 |
| K171962 | Klassic HD® Hip System | LPH | 2017-07-24 | 24 |
| K161073 | Klassic HD Hip System | LPH | 2016-10-19 | 184 |
| K143407 | Klassic HD Hip System | LZO | 2014-12-23 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Total Joint Othopedics, Inc..
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.
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.
- Total Joint Orthopedics, Inc. (23 510(k)s)
- Total Flow Medical Limited (1 510(k)s)
- Total Gloves Sdn Bhd (1 510(k)s)
- Total Medical Information Management Systems, Inc. (1 510(k)s)
- Total Water Treatment Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Total Joint Othopedics, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Total Joint Othopedics, Inc.” (first 2014, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Total Joint Othopedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Total Joint Othopedics, Inc. is 55 days. Since 2017: 55 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Total Joint Othopedics, Inc.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 3); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 3); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 2).
Next steps
- See all 8 Total Joint Othopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Total Joint Othopedics, Inc.'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.