MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM— 510(k) K082172

Clearance details

Applicant

Mako Surgical Corporation

Product code

Code HSX

Device class

Class 2

Regulation

21 CFR 888.3520

Advisory panel

Orthopedic

Date received

2008-08-01

Decision date

2008-11-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fort Lauderdale, FL, US

• K261609 — Freedom Partial Knee System2026-08-04
• K260796 — Tahoe Unicondylar Knee System with TiNbN Overcoat2026-04-02
• K251771 — Cambridge Partial Knee2025-12-16
• K251834 — Persona Partial Knee2025-08-15
• K251618 — MOTO Partial Knee System Extension2025-07-24

• K142530 — Partial Knee Application (PKA)2015-09-16
• K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM2015-03-20
• K141989 — MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM2014-11-13
• K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM2013-12-10
• K121064 — MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM2012-06-06

Injury

1,003

Other

1

Total

1,004

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-1385-2023 — stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedureClass II·Ongoing·Howmedica Osteonics Corp.·20230310
• Z-1386-2023 — stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedureClass II·Ongoing·Howmedica Osteonics Corp.·20230310

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082172.