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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Osteomed LP — Predicate Candidate Screening

29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

110 daysmedian FDA review time
198 days90th percentile
29clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K143338Argulated Locking PlatesOsteomed LP2015-04-011320
K133691EXTRIMILOCK ANKLE PLATING SYSTEMOsteomed LP2014-02-24840
K131445OSTEOMED EXTREMILOCK FOOT PLATING SYSTEMOsteomed LP2013-06-18290
K123885OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOROsteomed LP2013-06-031670
K123207PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSIOOsteomed LP2012-11-29480
K120015OSTEOMED WRIST PLATING SYSTEMOsteomed LP2012-04-241120
K111419OSTEOMED HAND FUSION SYSTEMOsteomed LP2011-10-071400
K111176OSTEOMED LOW PROFILE NEURO FIXATION SYSTEMOsteomed LP2011-08-151102
K102438PRIMALOK FACET FIXATION SYSTEMOsteomed LP2010-09-30351
K100354PRIMAL OK INTERSPINOUS FUSION SYSTEMOsteomed LP2010-08-171860
K091614OSTEOMED FOOT PLATING SYSTEMOsteomed LP2009-09-10990
K090522OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEMOsteomed LP2009-07-021260
K081876OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITEOsteomed LP2008-08-01300
K080694OSTEOMED MODULAR LOCKING FIXATION SYSTEMOsteomed LP2008-05-15650
K073065OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEMOsteomed LP2008-02-211140
K071105OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEMOsteomed LP2007-07-301020
K063298OSTEOMED HEADLESS CANNULATED SCREW SYSTEMOsteomed LP2007-03-021210
K063792OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEMOsteomed LP2007-03-02700
K062851OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, Osteomed LP2006-11-17530
K062863OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEMOsteomed LP2006-10-31360
K060536OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEMOsteomed LP2006-06-02940
K051798OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEMOsteomed LP2006-04-072760
K043434OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEMOsteomed LP2005-02-10590
K031701OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEMOsteomed LP2004-07-084020
K031936OSTEOMED ORTHODONTIC SCREW SYSTEMOsteomed LP2004-01-071980
K031708OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEMOsteomed LP2003-11-031540
K030790OSTEOMED ALVEOLAR DISTRACTION SYSTEMOsteomed LP2003-09-101820
K031155OSTEOMED SUBTALAR IMPLANT SYSTEMOsteomed LP2003-08-221330
K030448OSTEOMED 2.0 LOCKING PLATES AND SCREWSOsteomed LP2003-05-09870

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