Biomet Spine
Medical device manufacturer in Broomfield, CO.
23510(k) clearances
0PMA approvals
14recalls
Device types
- MAX Intervertebral Fusion Device With Bone… 5
- NKB Thoracolumbosacral Pedicle Screw System 5
- OVD Intervertebral Fusion Device With… 4
- KWQ Appliance, Fixation, Spinal Intervertebral… 2
- OVE Intervertebral Fusion Device With… 2
- NVR Intervertebral Fusion Device With Bone… 1
- MQP Spinal Vertebral Body Replacement Device 1
- KWP Appliance, Fixation, Spinal Interlaminal 1
- MQV Filler, Bone Void, Calcium Compound 1
- NKG Posterior Cervical Screw System 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K152622 | Alta ACDF SystemOVE · Traditional | 07/08/2016SE |
| K153695 | Biomet Spine Fusion SystemMAX · Special | 01/21/2016SE |
| K151974 | Polaris Spinal SystemNKB · Traditional | 11/13/2015SE |
| K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…OVE · Traditional | 08/12/2015SE |
| K151483 | Biomet Spine Fusion SystemMAX · Traditional | 07/31/2015SE |
| K151224 | Lineum OCT Spine SystemNKG · Traditional | 06/30/2015SE |
| K142634 | Biomet Spine Fusion SystemMAX · Traditional | 03/12/2015SE |
| K141791 | Biomet Fusion SystemOVD · Traditional | 10/09/2014SE |
| K141804 | Polaris Spinal System - Ha CoatedNKB · Traditional | 09/25/2014SE |
| K121130 | Polaris Spinal System-Ballista Spinal RodsNKB · Special | 06/15/2012SE |
| K112014 | Zyston Straight Spacer SystemMAX · Traditional | 10/17/2011SE |
| K103393 | Polaris Spinal SystemKWQ · Special | 02/02/2011SE |
| K093629 | Solitaire and Solitaire PEEK Anterior Spinal SystemOVD · Traditional | 03/09/2010SE |
| K091067 | 5.5 Polaris Spinal SystemNKB · Special | 07/14/2009SE |
| K082793 | Intergro DBMMQV · Traditional | 04/02/2009SE |
| K081952 | Synergy Spinal System (6.35 Polaris)NKB · Traditional | 10/07/2008SE |
| K081636 | Peek-Optima Alif SpacerMAX · Traditional | 08/07/2008SE |
| K081501 | Solitaire Anterior Spinal SystemOVD · Traditional | 07/02/2008SE |
| K081395 | Solitaire Peek-Optima Anterior Spinal SystemOVD · Traditional | 06/25/2008SE |
| K080646 | C-Tek Maxan Anterior Cervical Plate SystemKWQ · Traditional | 05/02/2008SE |
| K071377 | Polaris Be RodsKWP · Traditional | 08/06/2007SE |
| K063393 | Small Stature SpacersMQP · Traditional | 06/25/2007SE |
| K063139 | Spinal Stabilizing Sphere SystemNVR · Traditional | 04/04/2007SESU |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1253-2016 Class II | 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number…Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled… | 02/12/2016Terminated |
| Z-0203-2016 Class II | MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System.…The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws. | 09/29/2015Terminated |
| Z-2744-2015 Class II | Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate…Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440. | 08/05/2015Terminated |
| Z-2759-2015 Class II | Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers…Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft… | 07/22/2015Terminated |
| Z-2152-2015 Class II | Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw…Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result… | 03/12/2015Terminated |
| Z-1466-2015 Class II | Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides…Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine)… | 03/12/2015Terminated |
| Z-1465-2015 Class II | Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed…Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine)… | 03/12/2015Terminated |
| Z-0983-2015 Class II | Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline…The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the… | 08/22/2013Terminated |
| Z-0982-2015 Class II | Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102.…The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting… | 08/22/2013Terminated |
| Z-0978-2015 Class II | Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No.…The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the… | 08/22/2013Terminated |
| Z-1146-2015 Class II | Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is…Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification | 11/30/2012Terminated |
| Z-1069-2015 Class II | Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX…Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize… | 02/22/2012Terminated |
| Z-1089-2015 Class II | Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable…The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during… | 12/19/2011Terminated |
| Z-0220-2015 Class II | LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case.…Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component… | 03/09/2011Terminated |