Company ยท US
Biomet Spine
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2016. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 8 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 8 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 |
| HXC | Wrench | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 |
| NKG | Posterior Cervical Screw System | 1 |
| NVR | Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 2016 | K152622 | Alta ACDF System Biomet Spine | OVE |
| Jan 21, 2016 | K153695 | Biomet Spine Fusion System Biomet Spine, LLC | MAX |
| Nov 13, 2015 | K151974 | Polaris Spinal System Biomet Spine | NKB |
| Aug 12, 2015 | K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System Biomet Spine | OVE |
| Jul 31, 2015 | K151483 | Biomet Spine Fusion System Biomet Spine, LLC | MAX |
| Jun 30, 2015 | K151224 | Lineum OCT Spine System Biomet Spine | NKG |
| Mar 12, 2015 | K142634 | Biomet Spine Fusion System Biomet Spine, LLC | MAX |
| Oct 9, 2014 | K141791 | BIOMET FUSION SYSTEM Biomet Spine | OVD |
| Sep 25, 2014 | K141804 | POLARIS SPINAL SYSTEM - HA COATED Biomet Spine, LLC | NKB |
| Jun 15, 2012 | K121130 | POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS Biomet Spine | NKB |
| Oct 17, 2011 | K112014 | ZYSTON STRAIGHT SPACER SYSTEM Biomet Spine | MAX |
| Feb 2, 2011 | K103393 | POLARIS SPINAL SYSTEM Biomet Spine | KWQ |
| Mar 9, 2010 | K093629 | SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM Biomet Spine | OVD |
| Jul 14, 2009 | K091067 | 5.5 POLARIS SPINAL SYSTEM Biomet Spine | NKB |
| Apr 2, 2009 | K082793 | INTERGRO DBM Biomet Spine | MQV |
| Oct 7, 2008 | K081952 | SYNERGY SPINAL SYSTEM (6.35 POLARIS) Biomet Spine | NKB |
| Aug 7, 2008 | K081636 | PEEK-OPTIMA ALIF SPACER Biomet Spine | MAX |
| Jul 2, 2008 | K081501 | SOLITAIRE ANTERIOR SPINAL SYSTEM Biomet Spine | OVD |
| Jun 25, 2008 | K081395 | SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM Biomet Spine | OVD |
| May 2, 2008 | K080646 | C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM Biomet Spine | KWQ |
| Aug 6, 2007 | K071377 | POLARIS BE RODS Biomet Spine | KWP |
| Jun 25, 2007 | K063393 | SMALL STATURE SPACERS Biomet Spine | MQP |
| Apr 4, 2007 | K063139 | SPINAL STABILIZING SPHERE SYSTEM Biomet Spine | NVR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2016 | Biomet Spine, LLC 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230.
Product Usage:
The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for s Terminated |
OVD | K081501 |
| Nov 3, 2015 | Biomet Spine, LLC MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization. Terminated |
KWQ | K080646 K133518 |
| Sep 10, 2015 | Biomet Spine, LLC Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch.
The Lineum syste Terminated |
KWP | K122378 |
| Sep 9, 2015 | Biomet Spine, LLC Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440. Terminated |
KWQ | K080646 |
| Jul 20, 2015 | Biomet Spine, LLC Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component. Terminated |
NKB | K133746 |
| Apr 20, 2015 | Biomet Spine, LLC Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109
Product Usage:
Provides posterior fixation in the non-cervical spine with an interspinous fixation device. Terminated |
HXC | None listed |
| Apr 20, 2015 | Biomet Spine, LLC Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035
P_roduct Usage:
Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and var Terminated |
HXC | None listed |
| Feb 24, 2015 | Biomet Spine, LLC Set Screw 5.5 mm Rod - Model #7703-1600.
Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tul Terminated |
NKB | K122145 |
| Feb 11, 2015 | Biomet Spine, LLC Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. Terminated |
NKB | None listed |
| Feb 9, 2015 | Biomet Spine, LLC Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Ti Terminated |
MAX | None listed |
| Jan 15, 2015 | Biomet Spine, LLC Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into t Terminated |
OVD | K123767 |
| Jan 15, 2015 | Biomet Spine, LLC Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102.
Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into Terminated |
OVD | K123767 |
| Jan 14, 2015 | Biomet Spine, LLC Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204
Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF Terminated |
OVD | K123767 |
| Dec 16, 2014 | Biomet Spine LLC. LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case.
Product Usage:
The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in Terminated |
MAX | K102738 |