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

Kirschner Medical Corp. — Predicate Candidate Screening

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

87 daysmedian FDA review time

316 days90th percentile

76clearances measured

K-number	Device	Applicant	Decided	Review days
K940537	KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM	Kirschner Medical Corp.	1995-08-29	568
K936274	KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM	Kirschner Medical Corp.	1995-01-18	384
K942891	SUMMIT TOTAL HIP SYSTEM	Kirschner Medical Corp.	1994-11-02	135
K941486	INTEGRITY TOTAL HIP SYSTEM, NON-POROUS	Kirschner Medical Corp.	1994-09-20	176
K933843	LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM,	Kirschner Medical Corp.	1994-08-05	364
K935951	KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM	Kirschner Medical Corp.	1994-07-18	217
K934589	KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED	Kirschner Medical Corp.	1994-07-13	292
K935206	KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION	Kirschner Medical Corp.	1994-07-13	257
K934694	KIRSCHNER ZIRCONIA FEMORAL HEAD	Kirschner Medical Corp.	1994-05-18	230
K920188	THREADED PINS	Kirschner Medical Corp.	1993-05-12	483
K921837	MEDICAM 900 INSUFFLATOR WITH ACCESSORIES	Kirschner Medical Corp.	1993-02-05	294
K915500	LESTER PRESS FIT HIP PROSTHESIS	Kirschner Medical Corp.	1992-10-20	316
K912837	MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS	Kirschner Medical Corp.	1992-08-26	427
K920396	KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM	Kirschner Medical Corp.	1992-08-07	190
K922544	MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE	Kirschner Medical Corp.	1992-08-07	70
K914675	MODULAR FEMORAL HEAD WITH OFFSET TRUNION	Kirschner Medical Corp.	1992-08-07	294
K921672	INTER-HA HIP PROSTHESIS	Kirschner Medical Corp.	1992-08-07	121
K901507	MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS)	Kirschner Medical Corp.	1992-01-28	669
K913492	KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM	Kirschner Medical Corp.	1991-12-27	143
K913632	BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM	Kirschner Medical Corp.	1991-11-13	90
K913246	HYBRID FIT TOTAL HIP SYSTEM	Kirschner Medical Corp.	1991-10-18	88
K912933	MEDICAM LAPAROSCOPY ENDOSCOPES	Kirschner Medical Corp.	1991-10-15	102
K912922	DIMENSION-HA HIP PROSTHESIS	Kirschner Medical Corp.	1991-10-04	93
K901234	KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE	Kirschner Medical Corp.	1990-10-04	204
K902961	DIMENSION-II TOTAL HIP SYSTEM	Kirschner Medical Corp.	1990-10-03	90
K902279	KM-5 METAL BACKED ACETABULAR CUP	Kirschner Medical Corp.	1990-08-09	79
K901338	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	Kirschner Medical Corp.	1990-05-22	61
K901455	THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM	Kirschner Medical Corp.	1990-05-14	42
K900812	MEDICAM ARTHROSCOPE SYSTEMS	Kirschner Medical Corp.	1990-05-03	71
K895962	KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS	Kirschner Medical Corp.	1990-01-09	90
K895636	DIMENSION REVISION TOTAL HIP SYSTEM	Kirschner Medical Corp.	1989-12-14	86
K894068	KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM	Kirschner Medical Corp.	1989-12-08	183
K884690	KIRSCHNER SPINAL FIXATOR KMS-1	Kirschner Medical Corp.	1989-06-02	205
K883215	KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S	Kirschner Medical Corp.	1988-11-09	103
K881896	KIRSCHNER SUPER-FIXATION SYSTEM	Kirschner Medical Corp.	1988-07-28	84
K882241	KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM	Kirschner Medical Corp.	1988-06-29	33
K874939	SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED	Kirschner Medical Corp.	1988-02-02	62
K874643	KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS	Kirschner Medical Corp.	1988-01-06	54
K873970	KIRSCHNER UNICONDYLAR KNEE SYSTEM	Kirschner Medical Corp.	1987-12-31	93
K874547	KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED	Kirschner Medical Corp.	1987-12-18	45
K873620	NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE.	Kirschner Medical Corp.	1987-10-15	37
K873104	NEER-III GLENOID RESURFACING PROSTHESIS	Kirschner Medical Corp.	1987-10-15	69
K873621	NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS	Kirschner Medical Corp.	1987-10-15	37
K873073	KIRSCHNER NEER-III PROXIMAL HUMERUS	Kirschner Medical Corp.	1987-10-01	56
K871402	MURRAY/WELCH TOTAL HIP SYSTEM	Kirschner Medical Corp.	1987-07-16	99
K871401	KIRSCHNER MODULAR HIP SYSTEM	Kirschner Medical Corp.	1987-05-18	40
K870867	KM-4(TM) METAL-BACKED ACETABULAR CUP	Kirschner Medical Corp.	1987-05-08	66
K864924	KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM	Kirschner Medical Corp.	1987-03-20	94
K864337	SEGMENTAL SPINAL INSTRUMENTATION SYSTEM	Kirschner Medical Corp.	1986-12-16	42
K863896	AUSTIN MOORE HIP PROSTHESIS	Kirschner Medical Corp.	1986-11-19	43

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