Signature Orthopaedics Pty, Ltd.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under 2 spellings of the applicant name “Signature Orthopaedics Pty, Ltd.” (first 2012, latest 2026), across 16 product codes in 1 review panel. Median 510(k) review time under this name: 214 days. Since 2017 the median was 189 days, against 90 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 | 242 |
| 2013 | 0 | — |
| 2014 | 1 | 260 |
| 2015 | 1 | 132 |
| 2016 | 3 | 217 |
| 2017 | 4 | 147 |
| 2018 | 4 | 198 |
| 2019 | 5 | 258 |
| 2020 | 5 | 300 |
| 2021 | 2 | 246 |
| 2022 | 5 | 60 |
| 2023 | 2 | 190 |
| 2024 | 4 | 120 |
| 2025 | 7 | 217 |
| 2026 | 1 | 188 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Signature Orthopaedics Pty, Ltd. took a median 189 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 10 | 10 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 8 | 8 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 8 | 8 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 | 3 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 2 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
Plus 6 more product codes.
Review panels
- Orthopedic (45)
Most recent Signature Orthopaedics Pty, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | JDI | 2026-03-12 | 188 |
| K253239 | Active-V Total Knee System; World Total Knee System | MBH | 2025-12-23 | 85 |
| K251771 | Cambridge Partial Knee | HSX | 2025-12-16 | 189 |
| K243021 | Longboard Revision Hip Stem | LZO | 2025-08-07 | 314 |
| K242674 | Freedom Posterior Cervical Screws | NKG | 2025-05-13 | 249 |
| K242477 | Shoulder Soft Tissue Anchors | MBI | 2025-05-12 | 264 |
| K243043 | Origin Cemented Hip Stem | LZO | 2025-05-02 | 217 |
| K243029 | Origin TT Stem | LZO | 2025-03-11 | 165 |
| K243162 | World Liner | MEH | 2024-11-25 | 56 |
| K240683 | Rx Knee System | JWH | 2024-09-11 | 183 |
35 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Signature Orthopaedics Pty, Ltd..
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:
- Signature Orthopaedics Pty, Ltd. (44)
- Signature Orthopaedics Pty Limited (1)
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.
- Signature Orthodontics (2 510(k)s)
- Signature One Products, Inc. (1 510(k)s)
- Signature Orthopaedic Pty , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Signature Orthopaedics Pty, Ltd.?
FDA lists 45 510(k) clearances under 2 spellings of the applicant name “Signature Orthopaedics Pty, Ltd.” (first 2012, latest 2026), across 16 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 Signature Orthopaedics Pty, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Signature Orthopaedics Pty, Ltd. is 214 days. Since 2017: 189 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Signature Orthopaedics Pty, Ltd.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 10); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 8); MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, 8).
Next steps
- See all 45 Signature Orthopaedics Pty, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Signature Orthopaedics Pty, Ltd.'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.