SBI LATERAL RADIO CAPITELLUM— 510(k) K070236

Clearance details

Applicant

Small Bone Innovations, Inc.

Product code

Code JDB

Device class

Class 2

Regulation

21 CFR 888.3160

Advisory panel

Orthopedic

Date received

2007-01-25

Decision date

2007-02-21

Decision

Substantially Equivalent

Clearance type

Special

Location

Newyork, NY, US

• K222807 — TEMA Elbow system - Line extension2022-10-26
• K193247 — LATITUDE EV Total Elbow Arthroplasty2020-08-05
• K182461 — LATITUDE EV Total Elbow Arthroplasty2018-12-27
• K171010 — Latitude EV Total Elbow Arthroplasty2017-08-31
• K102180 — RHEAD RADIAL HEAD EXTENDED STEMS2010-12-20

• K130147 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)2013-05-03
• K112982 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )2012-04-02
• K092754 — SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-00612010-01-19
• K093550 — MINI RAIL EXTERNAL FIXATOR SYSTEM2010-01-07
• K073635 — SBI SR MTP TOE IMPLANT2008-03-19

Injury

352

Total

352

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-2428-2015 — Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.Class II·Terminated·Stryker Howmedica Osteonics Corp.·20150624
• Z-0098-2014 — Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. The recall was expanded on December 20, 2013 to include the following devices: rHead lateral assembly, radial head implant, sizes 2 through 4, Uni-elbow lateral assembly, radial implant assembly, sozes 2 through 4, ReMotion Left, large distal radial component, x-small, small, medium, and large, ReMotion Right, distal radial component, x-small, small, medium, and large.Class II·Terminated·Small Bone Innovations, Inc.·20130906

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070236.