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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 8 of 500

Device	Model / Reference	Registries	Class	Status
Polaris 5.5 Spinal System	14-505401	FDA UDI	Class II	Active
C-Thru Lordotic Anterior Spinal Sys	55001942	FDA UDI	Class II	Active
Array® Spinal System	94095J	FDA UDI	Class II	Active
Polaris 5.5 Spinal System	2000-5516	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	14-505404	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	14-506380R	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	14-578460R	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-583999	FDA UDI	Class II	Active
Zyston® Straight Interbody Fusion System	14-534876	FDA UDI	Class II	Active
Vital™	810M4540	FDA UDI	Class II	Active
EPIC™ Anterior Thoracolumbar Plate System	5012-7032	FDA UDI	Class II	Active
Vital™	804M8555	FDA UDI	Class II	Active
Timberline® Lateral Interbody Fusion System	8714-4030	FDA UDI	Class II	Active
Timberline® Lateral Interbody Fusion System	8711-4520	FDA UDI	Class II	Active
Vital™	805M6521	FDA UDI	Class II	Active
Vital™	810M6020	FDA UDI	Class II	Active
EPIC™ Anterior Thoracolumbar Plate System	5020-6020	FDA UDI	Class II	Active
Polaris™ 6.35 Spinal System	14-513195R	FDA UDI	Class II	Active
C-Tek® Maxan®	14-521522	FDA UDI	Class II	Active
Polaris™ 6.35 Spinal System	14-515555	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-583330	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-583635	FDA UDI	Class II	Active
Timberline® MPF Lateral Interbody Modular Plate Fixation System	8609-6045	FDA UDI	Class II	Active
C-Tek® Maxan® Anterior Cervical Plate System	14-521546B	FDA UDI	Class II	Active
Lineum® OCT	14-525256E	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	14-506180R	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-585160CL	FDA UDI	Class II	Active
Lineum Oct Spine System	14-524031E	FDA UDI	Class II	Active
Timberline Lateral Fusion System	8707-5010	FDA UDI	Class II	Active
Durango Stand-Alone Alif System	8509-0014	FDA UDI	Class II	Active
Polaris 5.5 Spine System	14-500844	FDA UDI	Class II	Active
Vitality®	704M9590	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	2000-2335E	FDA UDI	Class II	Active
Vital™ MIS Spinal Fixation System	824M5565	FDA UDI	Class II	Active
Vital™	809M6530	FDA UDI	Class II	Active
Vital™	720M7060	FDA UDI	Class II	Active
Timberline® Lateral Interbody Fusion System	8722-4025	FDA UDI	Class II	Active
Vitality®	707M6525	FDA UDI	Class II	Active
Gallery™ Laminoplasty System	14-523094	FDA UDI	Class II	Active
Vital™	805M6590	FDA UDI	Class II	Active
Concero™ Facet Screw System	7514-4037	FDA UDI	U	Active
Snowcap® Anterior Cervical Plate System	4432-1415	FDA UDI	Class II	Active
Timberline Mpf Lateral Modular Plate Fixation System	8607-6030	FDA UDI	Class II	Active
Vital™	802M9535	FDA UDI	Class II	Active
Vital™	803M6575	FDA UDI	Class II	Active
Breckenridge® Intervertebral Body/VBR Fusion System	8880-0110	FDA UDI	Class II	Active
Timberline® Lateral Interbody Fusion System	8713-5045	FDA UDI	Class II	Active
Polaris 5.5 Spinal System	14-512345R	FDA UDI	Class II	Active
C-Tek® Anterior Cervical Plate Sys	1100-0235T	FDA UDI	Class II	Active
Vail Oct Spinal Fixation System	7909-6105	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.