Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KLS-Martin L.P. — Predicate Candidate Screening
78 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
301 days90th percentile
78clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2026-02-20 | 92 | 0 |
| K254162 | KLS Martin Ixos System | KLS Martin L.P. | 2026-02-20 | 60 | 0 |
| K250988 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2025-12-11 | 255 | 0 |
| K250865 | KLS Martin IPS Forearm System | KLS-Martin L.P. | 2025-11-14 | 238 | 0 |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-M | KLS-Martin L.P. | 2025-11-10 | 88 | 0 |
| K250620 | KLS Martin Ixos System | KLS Martin L.P. | 2025-08-15 | 168 | 0 |
| K233721 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | 2024-09-17 | 301 | 0 |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024-08-16 | 98 | 0 |
| K241018 | KLS Martin Orthopedic Implants - MR Conditional | KLS-Martin L.P. | 2024-07-12 | 88 | 0 |
| K230211 | CranioXpand | KLS-Martin L.P. | 2023-11-21 | 299 | 0 |
| K222624 | KLS Martin LINOS Wrist System | KLS-Martin L.P. | 2023-05-25 | 267 | 0 |
| K222397 | KLS Martin Level One Rib Fixation System | KLS-Martin L.P. | 2023-03-29 | 233 | 0 |
| K221938 | KLS Martin Pure Pectus System | KLS Martin L.P. | 2023-03-28 | 270 | 0 |
| K220050 | KLS Martin IPS Distraction | KLS Martin L.P. | 2022-08-11 | 217 | 0 |
| K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2022-07-18 | 494 | 0 |
| K210228 | KLS Martin IPS Preprosthetic | KLS-Martin L.P. | 2022-07-08 | 526 | 0 |
| K210741 | KLS Martin Neuro Rongeurs | KLS-Martin L.P. | 2022-06-03 | 448 | 0 |
| K201052 | KLS Martin Individual Patient Solutions (IPS) Planning Syste | KLS-Martin L.P. | 2020-08-31 | 132 | 0 |
| K192979 | KLS Martin Individual Patient Solutions (IPS) Planning Syste | KLS-Martin L.P. | 2020-03-11 | 139 | 0 |
| K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2019-11-22 | 218 | 0 |
| K182889 | KLS Martin Individual Patient Solutions (IPS) Planning Syste | KLS-Martin L.P. | 2019-07-26 | 284 | 0 |
| K182789 | KLS Martin Individual Patient Solutions (IPS) Planning Syste | KLS-Martin L.P. | 2019-03-11 | 161 | 0 |
| K181241 | KLS Martin Individual Patient Solutions (IPS) Planning Syste | KLS-Martin L.P. | 2018-09-13 | 126 | 0 |
| K180962 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2018-08-13 | 123 | 0 |
| K173320 | KLS Martin L1 MMF System | KLS Martin L.P. | 2018-02-23 | 126 | 0 |
| K163579 | KLS Martin Individual Patient Solutions | KLS Martin L.P. | 2017-11-21 | 336 | 0 |
| K163315 | Internal Distraction - Sterile | KLS Martin L.P. | 2017-05-05 | 163 | 0 |
| K170124 | Level One Hand Plating System | KLS Martin L.P. | 2017-03-09 | 55 | 0 |
| K161259 | KLS Martin Cannulated Headless Screws | KLS Martin L.P. | 2016-12-19 | 229 | 0 |
| K161470 | Internal Distraction - Sterile | KLS Martin L.P. | 2016-12-01 | 188 | 0 |
| K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016-04-06 | 264 | 0 |
| K153482 | KLS Martin Thoracic Plating System | KLS-Martin L.P. | 2016-04-06 | 125 | 0 |
| K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) | KLS Martin L.P. | 2015-11-09 | 171 | 0 |
| K150771 | RxG Distraction System | KLS Martin L.P. | 2015-08-27 | 156 | 0 |
| K141489 | LINOS MOH HAND PLATING SYSTEM | KLS Martin L.P. | 2014-07-24 | 49 | 0 |
| K133304 | RXG DISTRACTION SYSTEM | KLS-Martin L.P. | 2014-05-15 | 199 | 0 |
| K121606 | RESORB-X G | KLS-Martin L.P. | 2013-01-17 | 230 | 0 |
| K122860 | KLS MARTIN RECON TALON | KLS Martin L.P. | 2012-11-14 | 57 | 0 |
| K112064 | RESORB X-G | KLS-Martin L.P. | 2012-03-23 | 248 | 0 |
| K083432 | DRILL FREE MMF SCREW | KLS Martin L.P. | 2009-03-31 | 131 | 0 |
| K080862 | SONICWELD RX (RESORB-X) | KLS-Martin L.P. | 2008-07-21 | 116 | 0 |
| K072764 | KLS MARTIN XTERNAL FIXATOR | KLS Martin L.P. | 2007-12-20 | 83 | 0 |
| K072707 | PATIENT CONTOURED MESH-PEEK (PCM-P) | KLS-Martin L.P. | 2007-12-19 | 85 | 0 |
| K070169 | KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - S | KLS Martin L.P. | 2007-03-26 | 67 | 0 |
| K062857 | KLS MARTIN QUICK DISC | KLS Martin L.P. | 2006-11-22 | 58 | 0 |
| K062570 | PATIENT CONTOURED MESH (PCM) | KLS-Martin L.P. | 2006-10-31 | 61 | 0 |
| K061507 | SONICWELD RX ENDOBROW FIXATION | KLS-Martin L.P. | 2006-09-21 | 112 | 0 |
| K051165 | KLS MARTIN STERNAL TALON | KLS-Martin L.P. | 2006-09-07 | 490 | 0 |
| K061271 | ERCH ARCH BAR, MODEL 38-690-00 | KLS-Martin L.P. | 2006-06-30 | 56 | 0 |
| K060177 | KLS MARTIN RIGID FIXATION - STERILE | KLS Martin L.P. | 2006-04-18 | 85 | 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