Signature Orthopaedics Pty, Ltd.: FDA clearances and approvals
Signature Orthopaedics Pty, Ltd. has 44 FDA 510(k) clearances (first 2012, latest 2026), across 16 product codes in 1 review panel. Median 510(k) review time: 202 days. Since 2017 its median was 189 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 242 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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, Signature Orthopaedics Pty, Ltd.'s cleared 510(k)s 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 |
| 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 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 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 (44)
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 |
34 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 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 Signature Orthopaedics Pty, Ltd. have?
Signature Orthopaedics Pty, Ltd. has 44 FDA 510(k) clearances (first 2012, latest 2026), across 16 product codes in 1 review panel.
How long does FDA take to clear Signature Orthopaedics Pty, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Signature Orthopaedics Pty, Ltd.'s cleared 510(k)s is 202 days. Since 2017: 189 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Signature Orthopaedics Pty, Ltd. make?
Its most frequent FDA product codes 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).
Has Signature Orthopaedics Pty, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Signature Orthopaedics Pty, Ltd. Related entities may recall under other names.
Next steps
- See all 44 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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.