SBI LATERAL RHEAD IMPLANT— 510(k) K062898

Clearance details

Applicant

Small Bone Innovations, Inc.

Product code

Code KWI

Device class

Class 2

Regulation

21 CFR 888.3170

Advisory panel

Orthopedic

Date received

2006-09-27

Decision date

2006-11-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

New York, NY, US

• K260624 — Arthrex Radial Head Replacement System2026-07-30
• K233592 — BioPoly Radial Head Implant2024-03-13
• K231188 — ALIGN Radial Head System2023-09-28
• K213563 — DePuy Synthes Radial Head Replacement System2022-03-18
• K212872 — Avenger Radial Head System2021-12-17

• K130147 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)2013-05-03
• K112982 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )2012-04-02
• K102180 — RHEAD RADIAL HEAD EXTENDED STEMS2010-12-20
• K092754 — SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-00612010-01-19
• K093550 — MINI RAIL EXTERNAL FIXATOR SYSTEM2010-01-07

Injury

490

Total

490

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-2663-2018 — Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2664-2018 — Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2665-2018 — Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2666-2018 — Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2667-2018 — Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2668-2018 — Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2669-2018 — Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2670-2018 — Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2671-2018 — Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2672-2018 — Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2673-2018 — Lateral Assembly, Radial Head Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2674-2018 — Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2675-2018 — Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• 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 K062898.