SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM— 510(k) K093629

Clearance details

Applicant

Biomet Spine

Product code

Code OVD

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2009-11-23

Decision date

2010-03-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Parsippany, NJ, US

• K262025 — Innovasis AxTiHA® Stand-Alone ALIF System +2 more2026-09-11
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• 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

• K152622 — Alta ACDF System2016-07-08
• K151974 — Polaris Spinal System2015-11-13
• K151064 — Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System2015-08-12
• K151224 — Lineum OCT Spine System2015-06-30
• K141791 — BIOMET FUSION SYSTEM2014-10-09

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-2292-2013 — Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.Class II·Terminated·Ebi, Llc·20130409

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093629.