MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM— 510(k) K121064
Substantially EquivalentMako Surgical Corporation
FDA 510(k) clearance K121064 for MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM, Substantially Equivalent on 2012-06-06. Applicant: Mako Surgical Corporation. Device class: 2.
Clearance details
- Applicant
- Mako Surgical Corporation
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fort Lauderdale, FL, US
Recent devices under product code OLO
view allMore clearances from Mako Surgical Corporation
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K121064
K-number listed on FDA's recall record- Z-1735-2022 — Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
- Z-2925-2018 — Stryker Mako Vizadisc Hip Procedure Tracking Kit
- Z-3131-2017 — Total Hip Application (THA) 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.
- Z-1411-2017 — MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
- Z-1193-2017 — Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
- Z-1583-2016 — RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
- Z-1588-2016 — MAKOplasty Hip Array Kit Laminate 150230
- 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.
- Z-0828-2015 — RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
- Z-0829-2015 — RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
- Z-0830-2015 — RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
- Z-1508-2016 — Robotic Arm Interactive Orthopedic System (RIO)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121064.
Data sourced from openFDA. This site is unofficial and independent of the FDA.