LANX FUSION SYSTEM- SA— 510(k) K123767

Clearance details

Applicant

Lanx, Inc.

Product code

Code OVD

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2012-12-07

Decision date

2013-03-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Broomfield, CO, US

• K262025 — Innovasis AxTiHA® Stand-Alone ALIF System +2 more2026-09-11
• K261408 — SABER-XA System2026-08-03
• K261809 — Interwedge® Standalone Lateral2026-07-31
• K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
• K260810 — Anteralign LS coverplate2026-06-10

• K131547 — LANX FUSION SYSTEM2013-07-12
• K131156 — LANX SPINAL FIXATION SYSTEM2013-05-24
• K121316 — LANX SPINAL FIZATION SYSTEM2012-09-10
• K122145 — LANX SPINAL FIXATION SYSTEM2012-08-17
• K121940 — LANX SPINAL FIXATION SYSTEM2012-08-02

Death

5

Injury

495

Total

500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0400-2014 — LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae.Class II·Terminated·Lanx, Inc.·20131104
• Z-0978-2015 — 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 System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.Class II·Terminated·Biomet Spine, LLC·20130822
• Z-0982-2015 — 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 the vertebrae for the screws utilized to anchor the plate to the vertebrae.Class II·Terminated·Biomet Spine, LLC·20130822
• Z-0983-2015 — 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 the vertebrae for the screws utilized to anchor the plate to the vertebrae. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.Class II·Terminated·Biomet Spine, LLC·20130822

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123767.