Newclip Technics: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Newclip Technics” (first 2006, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 93 days. Since 2017 the median was 87 days, against 98 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 | 0 | — |
| 2013 | 1 | 91 |
| 2014 | 1 | 109 |
| 2015 | 2 | 164 |
| 2016 | 3 | 159 |
| 2017 | 5 | 87 |
| 2018 | 4 | 139 |
| 2019 | 0 | — |
| 2020 | 1 | 95 |
| 2021 | 2 | 252 |
| 2022 | 1 | 49 |
| 2023 | 1 | 509 |
| 2024 | 2 | 164 |
| 2025 | 3 | 92 |
| 2026 | 4 | 84 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Newclip Technics took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 25 | 25 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 4 | 4 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
Review panels
- Orthopedic (34)
Most recent Newclip Technics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261511 | Xpert Ankle | HRS | 2026-07-28 | 82 |
| K261191 | Alians Elbow S | HRS | 2026-07-08 | 86 |
| K261038 | Xpert PFP | HRS | 2026-05-29 | 60 |
| K253906 | Xpert Hand | HRS | 2026-03-11 | 96 |
| K250767 | Newclip Patient-matched instrumentation non sterile PSI | PBF | 2025-10-01 | 202 |
| K250155 | Xpert Knee | HRS | 2025-04-23 | 92 |
| K243912 | Newclip Patient-matched instrumentation non sterile PSI | PBF | 2025-02-13 | 56 |
| K240415 | Newclip Patient-matched instrumentation non sterile PSI | PBF | 2024-11-07 | 269 |
| K241539 | Activmotion S | HRS | 2024-07-30 | 60 |
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | PBF | 2023-10-25 | 509 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Newclip Technics.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Newclip Technics?
FDA lists 34 510(k) clearances under the applicant name “Newclip Technics” (first 2006, latest 2026), across 4 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 Newclip Technics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Newclip Technics is 93 days. Since 2017: 87 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Newclip Technics?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 25); HWC (Screw, Fixation, Bone, 4); PBF (Orthopaedic Surgical Planning And Instrument Guides, 4).
Next steps
- See all 34 Newclip Technics clearances with predicates and recalls
- Run predicate analysis for product code HRS, Newclip Technics'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.