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

Instrument Makar, Inc. — Predicate Candidate Screening

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

86 daysmedian FDA review time
350 days90th percentile
28clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K002600LITWIN CRUICATE ANCHORInstrument Makar, Inc.2000-11-15860
K980999ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANTInstrument Makar, Inc.1998-11-062330
K963396BIOSPHERE SUTURE ANCHORInstrument Makar, Inc.1997-05-062510
K964364DISPOSABLE APRONInstrument Makar, Inc.1997-02-251160
K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.1996-11-193290
K960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHORInstrument Makar, Inc.1996-07-091510
K943249BIOABSORBABLE INTERFERENCE SCREWInstrument Makar, Inc.1995-07-313900
K944062LAPRASCOPIC GRASPERInstrument Makar, Inc.1995-02-231880
K942828MAKAR FULL AND HALF FACE SHIELDInstrument Makar, Inc.1995-02-232540
K930980INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREWInstrument Makar, Inc.1994-02-103500
K923841BONE SCREWSInstrument Makar, Inc.1993-10-274530
K912021MAKAR MINI CANNULATED CANCELLOUS SCREWSInstrument Makar, Inc.1991-11-221990
K910723BIODEGRADABLE SURGICAL STAPLEInstrument Makar, Inc.1991-03-12200
K905365INSTRUMENT MAKAR GRAVITY ASSIST SYSTEMInstrument Makar, Inc.1991-02-06770
K902854GRAVITY ASSISTInstrument Makar, Inc.1990-08-29610
K890973STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADEInstrument Makar, Inc.1989-03-22230
K890972HOOK TIP SURGICAL CAUTERY ELECTRODE BLADEInstrument Makar, Inc.1989-03-22230
K885311MENISCUS MENDER II LOOPInstrument Makar, Inc.1989-02-09420
K882407BOW & ARROW DRILL GUIDEInstrument Makar, Inc.1988-09-06880
K853597INSTRUMENT MAKAR DISPOSALBE LOOPInstrument Makar, Inc.1985-09-23270
K832978MENISCAL SUTURE GUNInstrument Makar, Inc.1983-12-121010
K830455STAPLES DESIGNED FOR ARTHROSCOPIC SURGInstrument Makar, Inc.1983-03-09280
K830456STAPLE INSERTER-EXTRACTOR FOR ARTHROSInstrument Makar, Inc.1983-03-09280
K821847I.M. ARTHROSCOPEInstrument Makar, Inc.1982-07-22300
K810720I.M. SCALPEL HANDLEInstrument Makar, Inc.1981-04-03170
K800444GOLDEN RETRIEVERS OR SILVER RETRIEVERSInstrument Makar, Inc.1980-03-0560
K800177I.M. BLADESInstrument Makar, Inc.1980-02-11140
K790674THE SURGICAL ASSISTANTInstrument Makar, Inc.1979-05-14350

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