RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM— 510(k) K112507

Clearance details

Applicant

Mako Surgical Corporation

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2011-08-30

Decision date

2012-03-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fort Lauderdale, FL, US

• K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
• K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
• K261205 — SPINEART Navigation Instrument System2026-07-29
• K261024 — TMINI Miniature Robotic System2026-07-24
• K262121 — Ion-L Navigated Instruments2026-07-24

• 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

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

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-2924-2018 — Stryker Mako Vizadisc Knee Procedure Tracking KitClass II·Terminated·Mako Surgical Corporation·20180724
• Z-3130-2017 — Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.Class II·Terminated·Mako Surgical Corporation·20170807
• Z-2741-2017 — MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.Class II·Terminated·Mako Surgical Corporation·20170607
• Z-0224-2016 — Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.Class II·Terminated·Mako Surgical Corporation·20150716
• Z-1128-2015 — Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.Class II·Terminated·Mako Surgical Corporation·20150122
• Z-1508-2016 — Robotic Arm Interactive Orthopedic System (RIO)Class II·Terminated·Mako Surgical Corporation·20140430

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112507.