Biomet Spine Fusion System— 510(k) K153695

Clearance details

Applicant

Biomet Spine, LLC

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2015-12-23

Decision date

2016-01-21

Decision

Substantially Equivalent

Clearance type

Special

Location

Broomfield, CO, US

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• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K151483 — Biomet Spine Fusion System2015-07-31
• K142634 — Biomet Spine Fusion System2015-03-12
• K141804 — POLARIS SPINAL SYSTEM - HA COATED2014-09-25

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

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-2397-2016 — Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.Class II·Terminated·Zimmer Biomet Spine, Inc·20160630
• Z-2398-2016 — Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.Class II·Terminated·Zimmer Biomet Spine, Inc·20160630

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153695.