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

Acromed Corp. — Predicate Candidate Screening

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

88 daysmedian FDA review time

336 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K980485	ISOLA SPINAL SYSTEM	Acromed Corp.	1998-10-21	254	0
K981714	TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM	Acromed Corp.	1998-06-30	46	0
K981113	PEDIATRIC PRC	Acromed Corp.	1998-05-29	63	0
K981274	ACROMED TIMX PLATE BASED LOW BACK SYSTEM	Acromed Corp.	1998-04-29	21	0
K980228	UNIVERSITY PLATE ANTERIOR SYSTEM	Acromed Corp.	1998-04-14	82	0
K974757	KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS	Acromed Corp.	1998-03-05	76	0
K972718	M-2 ANTERIOR PLATE SYSTEM	Acromed Corp.	1997-10-01	72	0
K970955	ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM	Acromed Corp.	1997-06-11	86	0
K971248	KANEDA SR ANTERIOR SPINAL SYSTEM	Acromed Corp.	1997-06-11	69	0
K970950	EASY ROD	Acromed Corp.	1997-06-03	81	0
K965102	ACROMED PEDICLE SCREW	Acromed Corp.	1997-05-08	139	1
K970462	ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM	Acromed Corp.	1997-04-03	56	0
K965046	ISOLA TWISTER CONNECTOR	Acromed Corp.	1997-03-14	86	0
K953978	ANTERIOR DYNAMIZED SYSTEM	Acromed Corp.	1997-02-19	546	0
K964007	ACROMED CABLE/WIRE PEDICLE SCREW	Acromed Corp.	1996-12-16	70	0
K962984	ISOLA PEDIATRIC COMPONENTS	Acromed Corp.	1996-11-27	118	0
K963639	ACROMED PEDICLE SCREW	Acromed Corp.	1996-11-14	63	0
K962645	ISOLA TWISTER CONNECTOR	Acromed Corp.	1996-10-22	106	0
K952236	ISOLA SYSTEM	Acromed Corp.	1996-01-22	255	0
K951657	VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDIC	Acromed Corp.	1995-08-21	133	0
K951116	ACROMED PEDICLE SCREW	Acromed Corp.	1995-08-11	154	0
K944737	ISOLA SPINE SYSTEM	Acromed Corp.	1995-06-22	269	0
K944756	ISOLA OPEN AND CLOSED SCREWS	Acromed Corp.	1995-05-30	246	0
K944736	VSP (VARIABLE SCREW PLACEMENT)	Acromed Corp.	1995-05-05	221	0
K943819	ISOLA ANTERIOR SYSTEM	Acromed Corp.	1995-02-09	188	0
K923703	KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV	Acromed Corp.	1993-05-20	300	0
K922504	ISOLA(R) TANDEM CONNECTOR	Acromed Corp.	1993-05-18	356	0
K921090	ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR	Acromed Corp.	1992-12-31	300	0
K920392	ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION	Acromed Corp.	1992-12-31	336	0
K904446	CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)	Acromed Corp.	1991-09-05	342	0
K911528	ISOLA(TM) SPINE SYSTEM - ILIAC SCREW	Acromed Corp.	1991-06-28	85	0
K911394	ISOLA(TM) SPINE SYSTEM--EYE ROD	Acromed Corp.	1991-06-21	84	0
K905826	ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR	Acromed Corp.	1991-03-21	80	0
K905184	ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK	Acromed Corp.	1991-02-15	88	0
K903376	ACROMED SACRAL SCREW	Acromed Corp.	1990-12-27	150	0
K895441	ACROMED BUTTON SPINAL WIRE	Acromed Corp.	1989-11-22	78	0
K895413	ACROMED DOUBLE SUBLAMINAR WIRE	Acromed Corp.	1989-11-22	78	0
K895439	ACROMED BEADED SUBLAMINAR WIRE	Acromed Corp.	1989-11-22	78	0
K873826	ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION	Acromed Corp.	1988-11-30	434	0
K874882	ACROMED CROSS ROD CONNECTOR	Acromed Corp.	1988-02-18	79	0
K842845	BONE MILL BONE GRINDER	Acromed Corp.	1984-10-25	97	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