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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 13 of 500

Device	Model / Reference	Registries	Class	Status
Silverton-D Deformity System	7722-8585	FDA UDI	Class II	Active
Concero Facet Screw System	7514-4537	FDA UDI	U	Active
Polaris 5.5 Spinal System	14-500376	FDA UDI	Class II	Active
Ballista(tm) Percutaneous Pedicle Screw System	14-500630	FDA UDI	Class II	Active
Silverton-D® Deformity System	7722-5550	FDA UDI	Class II	Active
Silverton-D® Deformity System	7718-6540	FDA UDI	Class II	Active
Lineum® OCT	14-525142E	FDA UDI	Class II	Active
Altius™ M-Ini™ Spinal System	1200-1220	FDA UDI	Class II	Active
Lineum® Oct Spine System	14-524509	FDA UDI	Class II	Active
Vitality®	701M6530	FDA UDI	Class II	Active
Polaris™ 4.75	14-587613CL	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	2000-5114	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-582120	FDA UDI	Class II	Active
Spinal System	132M2125	FDA UDI	Class I	Active
Polaris™ 5.5 Spinal System	14-503160	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	14-578307R	FDA UDI	Class II	Active
Ballista® Percutaneous	2000-3540E	FDA UDI	Class II	Active
Polaris™ 6.35 Spinal System	14-513265R	FDA UDI	Class II	Active
Lineum® OCT Spine System	14-524214	FDA UDI	Class II	Active
Vital™	812M9085	FDA UDI	Class II	Active
Vital™	806M8575	FDA UDI	Class II	Active
Lineum® Oct Spine System	14-524516	FDA UDI	Class II	Active
Polaris™ 6.35 Spinal System	14-573875	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-582045	FDA UDI	Class II	Active
Timberline Lateral Fusion System	8703-2508	FDA UDI	Class II	Active
Alta Stand-Alone Interbody Fusion System	8409-1105	FDA UDI	Class II	Active
Silverton-D Deformity System	7722-8520	FDA UDI	Class II	Active
Spinal Fixation System	7701-0080	FDA UDI	Class II	Active
C-Thru Lordotic Anterior Spinal Sys	55001906	FDA UDI	Class II	Active
Polaris (tm) 5.5 Spinal System	14-502640	FDA UDI	Class II	Active
Vitality®	07.02025.029	FDA UDI	Class II	Active
Durango® Stand-Alone ALIF System	8509-0012	FDA UDI	Class II	Active
Vital™	807M5525	FDA UDI	Class II	Active
Polaris 4.75 Ti Spinal System	14-583046	FDA UDI	Class II	Active
Timberline Lateral Fusion System	8703-4020	FDA UDI	Class II	Active
Alta Stand-Alone Interbody Fusion System	8409-2106	FDA UDI	Class II	Active
Polaris 4.75 Ti Spinal System	14-584136	FDA UDI	Class II	Active
Concero™ Facet Screw System	7514-3535	FDA UDI	U	Active
Polaris™ 4.75 Spinal System	14-563627	FDA UDI	Class II	Active
Polaris™ 4.75 Spinal System	14-563927	FDA UDI	Class II	Active
MaxAn® Anterior Cervical Plate System	14-522200	FDA UDI	Class II	Active
Polaris™ 5.5 Spinal System	14-578380	FDA UDI	Class II	Active
Zyston® Strut	101M2108	FDA UDI	Class II	Active
Polaris 4.75 Spinal System	14-562766	FDA UDI	Class II	Active
C-Tek® Maxan® Anterior Cervical Plate System	14-522130	FDA UDI	Class II	Active
Gallery™ Laminoplasty System	14-523099	FDA UDI	Class II	Active
Array® Spinal System	94385J	FDA UDI	Class II	Active
Vitality®+ Osteotomy	732M3221	FDA UDI	Class I	Active
Polaris 4.75 Spinal System	14-562541	FDA UDI	Class II	Active
Polaris™ 6.35 Spinal System	14-513870	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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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.