Total Joint Orthopedics, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Total Joint Orthopedics, Inc.” (first 2010, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 60 days. Since 2017 the median was 54 days, against 102 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 |
|---|---|---|
| 2012 | 1 | 121 |
| 2013 | 0 | — |
| 2014 | 4 | 83 |
| 2015 | 5 | 30 |
| 2016 | 2 | 68 |
| 2017 | 1 | 28 |
| 2018 | 2 | 40 |
| 2019 | 2 | 66 |
| 2020 | 1 | 21 |
| 2021 | 1 | 60 |
| 2022 | 2 | 294 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 58 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Total Joint Orthopedics, Inc. took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 13 | 13 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 4 | 4 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 2 | 2 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 | 1 |
Review panels
- Orthopedic (23)
Most recent Total Joint Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261734 | Klassic Infection Spacer System | JWH | 2026-07-23 | 58 |
| K220483 | Platform® Acetabular System | LZO | 2022-09-23 | 217 |
| K211877 | Klassic Knee System | JWH | 2022-06-22 | 370 |
| K211602 | Klassic Knee System | JWH | 2021-07-23 | 60 |
| K202740 | Klassic Knee System Tibial Inserts, PS-Max | JWH | 2020-10-09 | 21 |
| K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly | JWH | 2019-03-29 | 98 |
| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly | JWH | 2019-03-15 | 35 |
| K180929 | Klassic HD® Hip System | LZO | 2018-05-09 | 30 |
| K180159 | Klassic® Knee System | JWH | 2018-03-09 | 49 |
| K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly | OQG | 2017-10-27 | 28 |
13 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-09-23.
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 Othopedics, Inc. (8 510(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 Orthopedics, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Total Joint Orthopedics, Inc.” (first 2010, latest 2026), across 6 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 Orthopedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Total Joint Orthopedics, Inc. is 60 days. Since 2017: 54 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Total Joint Orthopedics, Inc.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 13); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 4); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 2).
Next steps
- See all 23 Total Joint Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Total Joint Orthopedics, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.