LANX FUSION SYSTEM— 510(k) K102738

Clearance details

Applicant

Lanx, LLC

Product code

Code OVD

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2010-09-22

Decision date

2011-02-10

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

• K120399 — LANX SPINAL FIXATION SYSTEM2012-03-09
• K103040 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)2011-02-08
• K093285 — MODIFICATION TO LANX SPINAL FIXATION SYSTEM2009-12-10
• K082774 — LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE2008-10-21
• K073144 — LANX INTERVERTEBRAL BODY FUSION DEVICE2008-01-24

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-0220-2015 — 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 skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.Class II·Terminated·Biomet Spine LLC.·20110309

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102738.