Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Newclip Technics — Predicate Candidate Screening
34 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
269 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261511 | Xpert Ankle | Newclip Technics | 2026-07-28 | 82 | 0 |
| K261191 | Alians Elbow S | Newclip Technics | 2026-07-08 | 86 | 0 |
| K261038 | Xpert PFP | Newclip Technics | 2026-05-29 | 60 | 0 |
| K253906 | Xpert Hand | Newclip Technics | 2026-03-11 | 96 | 0 |
| K250767 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025-10-01 | 202 | 0 |
| K250155 | Xpert Knee | Newclip Technics | 2025-04-23 | 92 | 0 |
| K243912 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2025-02-13 | 56 | 0 |
| K240415 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2024-11-07 | 269 | 0 |
| K241539 | Activmotion S | Newclip Technics | 2024-07-30 | 60 | 0 |
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | 2023-10-25 | 509 | 0 |
| K221395 | Footmotion Plating System | Newclip Technics | 2022-07-01 | 49 | 0 |
| K202803 | Activmotion S DTO | Newclip Technics | 2021-12-16 | 449 | 0 |
| K213214 | Xpert Wrist | Newclip Technics | 2021-11-24 | 56 | 0 |
| K202307 | Activ Fuse | Newclip Technics | 2020-11-17 | 95 | 0 |
| K172485 | Footmotion HammerToe | Newclip Technics | 2018-03-02 | 197 | 0 |
| K173746 | Activmotion Range | Newclip Technics | 2018-02-27 | 81 | 0 |
| K173641 | Activ Ankle | Newclip Technics | 2018-01-16 | 53 | 0 |
| K171372 | Alians Elbow Locking Plating System | Newclip Technics | 2018-01-04 | 239 | 0 |
| K172596 | Large Screws Range | Newclip Technics | 2017-10-02 | 34 | 0 |
| K171510 | Footmotion Plating System | Newclip Technics | 2017-09-08 | 107 | 0 |
| K170843 | Alians Fragment Specific | Newclip Technics | 2017-06-16 | 87 | 0 |
| K170012 | Foot and Hand Motion | Newclip Technics | 2017-04-24 | 111 | 0 |
| K170310 | Alians Clavicle range | Newclip Technics | 2017-03-30 | 57 | 0 |
| K161448 | Footmotion Plating System | Newclip Technics | 2016-10-31 | 159 | 0 |
| K152289 | Alians Elbow Locking Plating System | Newclip Technics | 2016-08-17 | 370 | 0 |
| K160617 | Large Screws Range | Newclip Technics | 2016-06-03 | 92 | 0 |
| K141548 | HIGH TIBIAL OSTEOTOMY SYSTEM | Newclip Technics | 2015-01-30 | 233 | 0 |
| K143061 | Activ Ankle Locking Plating System | Newclip Technics | 2015-01-26 | 94 | 0 |
| K142502 | ALIANS ULNA LOCKING PLATING SYSTEM | Newclip Technics | 2014-12-23 | 109 | 0 |
| K130774 | UNIVERSAL DISTAL RADIUS SYSTEM | Newclip Technics | 2013-06-19 | 91 | 0 |
| K100944 | CLAVICLE LOCKING PLATE SYSTEM | Newclip Technics | 2010-10-22 | 199 | 0 |
| K091118 | FOOT AND HAND MOTION SYSTEM | Newclip Technics | 2009-12-16 | 243 | 0 |
| K063095 | HUMERUS LOCKING PLATING SYSTEM | Newclip Technics | 2006-12-22 | 73 | 0 |
| K061917 | DISTAL RADIUS LOCKING PLATING SYSTEM | Newclip Technics | 2006-08-28 | 53 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda