Company · US

Pioneer Surgical Technology

FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2026. Name variants (Inc, Corp, punctuation) are merged.

77510(k) clearances (1 in 12 months)

10recalls (0 in 12 months)

8recalls that name a 510(k)

Product codes

Code	Device	Records
NKB	Thoracolumbosacral Pedicle Screw System	16
JDQ	Cerclage, Fixation	14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	12
HWC	Screw, Fixation, Bone	9
MQV	Filler, Bone Void, Calcium Compound	7
KWP	Appliance, Fixation, Spinal Interlaminal	6
HRS	Plate, Fixation, Bone	3
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	3
MNI	Orthosis, Spinal Pedicle Fixation	3
MQP	Spinal Vertebral Body Replacement Device	3
HTN	Washer, Bolt Nut	2
GEI	Electrosurgical, Cutting & Coagulation & Accessories	1
GXZ	Electrode, Needle	1
HSB	Rod, Fixation, Intramedullary And Accessories	1
HWR	Driver, Prosthesis	1
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	1
MNH	Orthosis, Spondylolisthesis Spinal Fixation	1
MVH	Device, Detection, Sulfide	1
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	1
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jul 16, 2026	K261271	Cable-Ready® Cable Grip System Pioneer Surgical Technology, Inc.	JDQ
Jul 11, 2025	K251436	Resolve Anterior Cervical Plate System Pioneer Surgical Technology, Inc.	KWQ
Nov 18, 2022	K222493	CODA Anterior Cervical Plate System Pioneer Surgical Technology, Inc.	KWQ
Jun 23, 2021	K211408	CervAlign® Anterior Cervical Plate System Pioneer Surgical Technology, Inc.	KWQ
Nov 26, 2019	K192396	Streamline MIS Spinal Fixation System Pioneer Surgical Technology, Inc.	NKB
Apr 10, 2014	K140696	STREAMLINE TL SPINAL FIXATION SYSTEM Pioneer Surgical Technology, Inc.	NKB
Mar 27, 2014	K133455	CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC Pioneer Surgical Technology, Inc.	MAX
Feb 10, 2014	K133623	C-PLUS Pioneer Surgical Technology, Inc.	ODP
Feb 7, 2014	K132050	NB3D BONE VOID FILLER Pioneer Surgical Technology, Inc.	MQV
Jan 27, 2014	K133785	TRITIUM STERNAL CABLE PLATE SYSTEM Pioneer Surgical Technology, Inc.	JDQ
Dec 24, 2013	K131724	PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE Pioneer Surgical Technology, Inc.	MQP
Jun 27, 2013	K131100	STREAMLINE TL SPINAL SYSTEM Pioneer Surgical Technology, Inc.	NKB
Jun 5, 2013	K130427	PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM Pioneer Surgical Technology, Inc.	KWQ
Apr 1, 2013	K130286	STREAMLINE MIS SPINAL FIXATION SYSTEM Pioneer Surgical Technology, Inc.	NKB
Nov 7, 2012	K121725	PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM Pioneer Surgical Technology, Inc.	KWP
Oct 12, 2012	K122293	PIONEER STERNAL CABLE PLATE SYSTEM Pioneer Surgical Technology, Inc.	HRS
Jul 26, 2012	K120016	PIONEER STERNAL ASSIST IMPLANT SYSTEM Pioneer Surgical Technology, Inc.	HRS
May 7, 2012	K120724	PIONEER LATERAL PLATE SYSTEM Pioneer Surgical Technology, Inc.	KWQ
Mar 12, 2012	K112757	PIONEER POSTERIOR CERVICO THORACIC SYSTEM Pioneer Surgical Technology, Inc.	KWP
Jan 26, 2012	K113218	PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM Pioneer Surgical Technology, Inc.	NQW
Nov 22, 2011	K111944	NB3D BONE VOID FILLER Pioneer Surgical Technology, Inc.	MQV
Sep 28, 2011	K112496	PIONEER CROSSFUSE II IBF/VBR SYSTEM Pioneer Surgical Technology, Inc.	MAX
Aug 24, 2011	K111528	PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES Pioneer Surgical Technology, Inc.	KWQ
Aug 23, 2011	K111502	STREAMLINE TL SPINAL SYSTEM Pioneer Surgical Technology, Inc.	NKB
May 12, 2011	K110692	STREAMLINE TL SPINAL SYSTEM Pioneer Surgical Technology, Inc.	NKB
Apr 29, 2011	K110561	FORTROSS BONE VOID FILLER Pioneer Surgical Technology	MQV
Mar 23, 2011	K110367	PIONEER SPINAL PROCESS FUSION PLATE Pioneer Surgical Technology, Inc.	KWP
Mar 7, 2011	K101790	QUANTUM SPINAL SYSTEM, QUANTUM MIS Pioneer Surgical Technology	NKB
Oct 22, 2010	K101525	PIONEER SPINOUS PROCESS FUSION PLATE Pioneer Surgical Technology	KWP
Oct 20, 2010	K102903	PIONEER CANNULATED SCREW SYSTEM Pioneer Surgical Technology, Inc.	HWC
Aug 11, 2010	K093692	QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES Pioneer Surgical Technology	NKB
Aug 10, 2010	K093771	QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM Pioneer Surgical Technology	MNH
Jun 4, 2010	K100708	PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES Pioneer Surgical Technology	KWQ
Apr 22, 2010	K100361	NANOSS BONE VOID FILLER Pioneer Surgical Technology	MQV
Feb 19, 2010	K092295	PIONEER POSTERIOR CERVICO-THORACIC SYSTEM Pioneer Surgical Technology	KWP
Nov 17, 2009	K091031	PIONEER SURGICAL NANOSS BVF-E Pioneer Surgical Technology	MQV
Jun 12, 2009	K083449	E-MATRIX GRAFT BONE EXTENDER Pioneer Surgical Technology	MQV
Apr 28, 2009	K090222	PIONEER LUMBAR PLATE SYSTEM Pioneer Surgical Technology	KWQ
Feb 25, 2009	K083663	PACP Pioneer Surgical Technology	KWQ
Aug 25, 2008	K081558	PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC Pioneer Surgical Technology	MQV
Jun 6, 2008	K073229	NERVE MONITORING CABLE Pioneer Surgical Technology	GXZ
May 13, 2008	K073177	PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM Pioneer Surgical Technology	MAX
Mar 20, 2008	K080518	PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM Pioneer Surgical Technology	NKB
Mar 20, 2008	K080504	PIONEER LOWTOP SPINAL ROD SYSTEM Pioneer Surgical Technology	NKB
Jan 28, 2008	K080026	QUANTUM-MIS CANNULATED SYSTEM Pioneer Surgical Technology	MNI
Jan 10, 2008	K072703	PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM Pioneer Surgical Technology	KWQ
Oct 12, 2007	K072187	PIONEER LOWTOP SPINAL ROD SYSTEM Pioneer Surgical Technology	MNI
Jul 3, 2007	K070973	QUANTUM SPINAL SYSTEM Pioneer Surgical Technology	NKB
Mar 29, 2007	K070551	MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM Pioneer Surgical Technology	NKB
Jul 24, 2006	K061151	PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) Pioneer Surgical Technology	MQP

Newest 50 of 77.

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Sep 9, 2014	PIONEER SURGICAL TECHNOLOGY, INC. Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fi Terminated	NKB	K130286
Sep 3, 2014	PIONEER SURGICAL TECHNOLOGY, INC. STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY Terminated	KWP	K112757
Jul 17, 2014	PIONEER SURGICAL TECHNOLOGY, INC. Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall incl Terminated	JDQ	K133785
Nov 27, 2007	Pioneer Surgical Technology Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855 Terminated	HWR	None listed
May 18, 2006	Pioneer Surgical Technology Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette, MI; Distributed by Zimmer, Warsaw, IN. Terminated	HWC	K003496
Oct 7, 2005	Pioneer Surgical Technology Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40. Terminated	NKB	K041167
Oct 7, 2005	Pioneer Surgical Technology Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45. Terminated	NKB	None listed
Aug 31, 2005	Pioneer Surgical Technology Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP. Terminated	MVH	K041156
Feb 27, 2004	Pioneer Surgical Technology Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001. Terminated	HWC	K990804
Jun 21, 2003	Pioneer Surgical Technology StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer Terminated	HWC	K990804

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