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

Blackstone Medical, Inc. · Predicate Candidate Screening

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

61 daysmedian FDA review time

169 days90th percentile

45clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K093926	FIREBIRD SPINAL FIXATION SYSTEM	Blackstone Medical, Inc.	2010-07-28	218	0
K100614	HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL	Blackstone Medical, Inc.	2010-05-04	61	0
K092624	FIREBIRD SPINAL FIXATION SYSTEM	Blackstone Medical, Inc.	2009-09-25	30	1
K082797	BLACKSTONE PEDICLE SCREW SYSTEM	Blackstone Medical, Inc.	2008-10-17	24	0
K081684	BLACKSTONE PEDICLE SCREW SYSTEM	Blackstone Medical, Inc.	2008-09-15	90	3
K082235	BLACKSTONE PILLAR XL PEEK SPACERS	Blackstone Medical, Inc.	2008-09-04	28	0
K081849	BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVI	Blackstone Medical, Inc.	2008-08-28	59	1
K081177	BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM	Blackstone Medical, Inc.	2008-07-23	89	0
K080394	BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT	Blackstone Medical, Inc.	2008-03-13	29	0
K080407	BLACKSTONE SFS PARALLEL ROD CONNECTORS	Blackstone Medical, Inc.	2008-03-13	28	1
K073420	BLACKSTONE ASCENT MULTIAXIAL SCREWS	Blackstone Medical, Inc.	2008-02-14	71	0
K073654	BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR	Blackstone Medical, Inc.	2008-01-24	29	0
K061229	UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM	Blackstone Medical, Inc.	2006-07-24	83	0
K060350	CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM	Blackstone Medical, Inc.	2006-02-24	14	0
K051246	CONSTRUX MINI PEEK VBR SYSTEM	Blackstone Medical, Inc.	2005-06-14	29	0
K043548	BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM	Blackstone Medical, Inc.	2005-06-14	173	0
K050892	HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM	Blackstone Medical, Inc.	2005-05-11	33	2
K043338	BLAKSTONE LAMINOPLASTY FIXATION SYSTEM	Blackstone Medical, Inc.	2005-02-18	77	0
K042514	MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM	Blackstone Medical, Inc.	2004-10-07	21	2
K042100	BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNE	Blackstone Medical, Inc.	2004-09-20	47	0
K041939	BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC L	Blackstone Medical, Inc.	2004-08-17	29	0
K033702	BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM	Blackstone Medical, Inc.	2004-03-31	127	0
K033980	BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)	Blackstone Medical, Inc.	2004-03-03	71	0
K040034	BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER	Blackstone Medical, Inc.	2004-02-11	34	0
K032700	BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS	Blackstone Medical, Inc.	2003-10-09	37	0
K030744	BLACKSTONE SURGICAL TITANIUM MESH	Blackstone Medical, Inc.	2003-06-27	109	0
K030581	BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MOD	Blackstone Medical, Inc.	2003-06-26	122	0
K030197	BLACKSTONE POSTERIOR CERVICAL SYSTEM	Blackstone Medical, Inc.	2003-06-12	142	1
K030595	BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM	Blackstone Medical, Inc.	2003-04-24	58	0
K030862	BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR	Blackstone Medical, Inc.	2003-04-17	30	0
K022965	BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE	Blackstone Medical, Inc.	2003-03-28	203	0
K030241	MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM	Blackstone Medical, Inc.	2003-02-21	29	0
K023498	MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM	Blackstone Medical, Inc.	2002-11-13	26	0
K022605	BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER	Blackstone Medical, Inc.	2002-08-21	15	0
K022399	BLACKSTONE SPINAL FIXATION SYSTEM SPACER	Blackstone Medical, Inc.	2002-08-06	14	0
K020620	BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLAT	Blackstone Medical, Inc.	2002-05-23	87	0
K020600	BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHE	Blackstone Medical, Inc.	2002-05-22	89	0
K020674	BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW	Blackstone Medical, Inc.	2002-04-03	33	0
K013885	BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS	Blackstone Medical, Inc.	2002-02-01	70	0
K012184	BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM	Blackstone Medical, Inc.	2002-01-30	202	0
K013558	BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW	Blackstone Medical, Inc.	2002-01-23	90	0
K003735	BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-C	Blackstone Medical, Inc.	2001-05-08	155	0
K994217	BLACKSTONE SPINAL FIXATION SYSTEM	Blackstone Medical, Inc.	2000-02-28	75	0
K974885	BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM	Blackstone Medical, Inc.	1998-06-17	169	0
K972768	BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM	Blackstone Medical, Inc.	1997-09-25	63	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