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BIOMET SPINE LLC

Last updated May 24, 2026

What BIOMET SPINE LLC makes

Biomet Spine LLC manufactures spinal fixation systems, including bone-screw and trans-facet-screw internal fixation devices for both sterile and non-sterile use, as well as polymeric spinal interbody and fusion cages. Their portfolio also includes vertebral body prostheses, interspinous spinal fixation implants, and trial spinal implants designed for surgical applications. Systems like the Timberline Lateral Fusion System and Vital™ MIS Spinal Fixation System are tailored for lateral and minimally invasive spinal procedures, respectively.

The company’s devices are regulated under FDA classifications, including Class I, Class II, and Unclassified (U) devices, and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates within the United States, adhering to applicable U.S. regulatory requirements for spinal implants and fixation systems.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Biomet Spine LLC manufacture?

Biomet Spine LLC specializes in spinal fixation and reconstruction devices. Their portfolio includes bone-screw and trans-facet-screw internal fixation systems (both sterile and non-sterile), polymeric spinal interbody and fusion cages, vertebral body prostheses, interspinous spinal fixation implants, and trial spinal implants. These devices are designed for surgical applications to stabilize, fuse, or replace spinal segments, such as systems like the Timberline Lateral Fusion System for lateral procedures or the Vital™ MIS Spinal Fixation System for minimally invasive surgeries.

Where is Biomet Spine LLC based, and how does that affect its regulatory oversight?

Biomet Spine LLC is based in the United States. Since it operates within the U.S., its devices are subject to FDA regulatory requirements, including classification under FDA categories such as Class I, Class II, or Unclassified (U). The company’s devices are also listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.

Which regulatory registries or databases list Biomet Spine LLC’s devices?

Biomet Spine LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency and allows healthcare providers, regulators, and other stakeholders to identify and track the company’s authorized spinal fixation and reconstruction products, including systems like the Silverton-D® Deformity System or the ALTIUS M-INI OCT Spine System.

How are Biomet Spine LLC’s devices classified under U.S. regulations?

Biomet Spine LLC’s devices fall under different FDA classifications depending on their risk and intended use. For example, bone-screw fixation systems may be classified as Class II due to their moderate risk, while simpler devices like certain polymeric spinal cages might qualify as Class I. Some devices, such as specialized trial implants, may be Unclassified (U) pending further regulatory evaluation. Classification determines the regulatory pathway and requirements for authorization.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: zimmerbiomet.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)447-3625
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 018577570

Catalogue (32639)

Page 15 of 500

Device	Model / Reference	Registries	Class	Status
Polaris 4.75 Ti Spinal System	14-582995	FDA UDI	Class II	Active
Polaris 6.35 Ti Spinal System	14-515550	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	2000-4295	FDA UDI	Class II	Active
Lineum® OCT Spine System	14-524194	FDA UDI	Class II	Active
Vital™ MIS Spinal Fixation System	825M1555	FDA UDI	Class II	Active
Vital™	816M5600	FDA UDI	Class II	Active
Vital™	812M9010	FDA UDI	Class II	Active
Ballista™ Percutaneous	14-500675	FDA UDI	Class II	Active
Polaris™ 6.35 Spinal System	14-513570R	FDA UDI	Class II	Active
Polaris 4.75 Ti Spinal System	14-584970	FDA UDI	Class II	Active
Cypher™ Mis System	2000-3460J	FDA UDI	Class II	Active
Vitality®+ Osteotomy	732M0514	FDA UDI	Class I	Active
Polaris 4.75 Spinal System	14-563923	FDA UDI	Class II	Active
Gallery Laminoplasty System	14-523084	FDA UDI	Class II	Active
Vail Oct Spinal Fixation System	7915-4029	FDA UDI	Class II	Active
Altius Oct Spine System	1200-2732	FDA UDI	Class II	Active
Vitality®	07.02005.258	FDA UDI	Class II	Active
Altius Oct Post. Spine Sys.	1200-2140	FDA UDI	Class II	Active
Polaris 5.5 Sst Spine Sys	14-506260	FDA UDI	Class II	Active
Spinal Fixation System	7707-5150	FDA UDI	Class II	Active
Polaris (tm) 5.5 Spinal System	14-502550	FDA UDI	Class II	Active
Cypher™ MIS System	14-571650	FDA UDI	Class II	Active
Ballista Percutaneous Pedicle Screw System	2000-3530	FDA UDI	Class II	Active
Vital™	812M1215	FDA UDI	Class II	Active
Vital™	810M7535	FDA UDI	Class II	Active
Silverton-D® Deformity System	7709-5575	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	14-578245R	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-583399	FDA UDI	Class II	Active
Array® Spinal System	94080	FDA UDI	Class II	Active
Timberline® Lateral Interbody Fusion System	8701-2540	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-584960	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-584121	FDA UDI	Class II	Active
Cypher™ Mis System	2000-3290J	FDA UDI	Class II	Active
Polaris 4.75 Spinal System	14-563958	FDA UDI	Class II	Active
Polaris 4.75 Ti Spinal System	14-580912N	FDA UDI	Class II	Active
Vail Oct Spinal Fixation System	7909-0030	FDA UDI	Class II	Active
Polaris 4.75 Ti Spinal System	14-585351CL	FDA UDI	Class II	Active
Polaris 4.75 Ti Spinal System	14-584885	FDA UDI	Class II	Active
Timberline® Lateral Interbody Fusion System	8707-5525	FDA UDI	Class II	Active
Polaris 5.5 Multiaxial Sys	14-592699	FDA UDI	Class II	Active
Polaris 4.75 Ti Spinal System	14-582785	FDA UDI	Class II	Active
Solitaire-C Cervical Spacer	14-520789	FDA UDI	Class II	Active
Spine System	LV00248	FDA UDI	Class II	Active
Cypher™ Mis System	2000-3307J	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	2000-7765C	FDA UDI	Class II	Active
Timberline® MPF Lateral Interbody Modular Plate Fixation System	8622-5020	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-585130CH	FDA UDI	Class II	Active
Silverton-D® Deformity System	7739-8560	FDA UDI	Class II	Active
Silverton® Spinal Fixation System	7738-8540	FDA UDI	Class II	Active
Silverton-D® Deformity System	7736-9500	FDA UDI	Class II	Active

Related Companies

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FDA Recalls (14)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Biomet Spine LLC has 14 FDA recall records initiated between March 9, 2011, and February 12, 2016, all marked as terminated. The reasons include dimensional inconsistencies in components such as sleeves, drills, and screws (e.g., undersized or oversized diameters), mislabeling of product identifiers or dimensions, non-compliance with internal specifications for fatigue strength, and incomplete design control activities. Additional recalls involved supplier withdrawals for component updates, incorrect lordotic angle labeling, and missing locking features in surgical instruments.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Feb 12, 2016	Z-1253-2016	—	terminated	Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees.
Sep 29, 2015	Z-0203-2016	—	terminated	The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
Aug 5, 2015	Z-2744-2015	—	terminated	Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.
Jul 22, 2015	Z-2759-2015	—	terminated	Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.
Mar 12, 2015	Z-1465-2015	—	terminated	Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.
Mar 12, 2015	Z-1466-2015	—	terminated	Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.
Mar 12, 2015	Z-2152-2015	—	terminated	Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
Aug 22, 2013	Z-0983-2015	—	terminated	The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve.
Aug 22, 2013	Z-0978-2015	—	terminated	The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft.
Aug 22, 2013	Z-0982-2015	—	terminated	The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.
Nov 30, 2012	Z-1146-2015	—	terminated	Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Feb 22, 2012	Z-1069-2015	—	terminated	Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.
Dec 19, 2011	Z-1089-2015	—	terminated	The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.
Mar 9, 2011	Z-0220-2015	—	terminated	Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.