510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Sbi Lateral Rhead Implant

K062898510(k) TraditionalCleared Nov 13, 200647-day reviewClass II21 CFR 888.3170Recalls 14

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Small Bone Innovations, Inc. · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

Cleared on Nov 13, 2006 after a 47-day review. The FDA summary names no predicate by number. It has been recalled 14 times.

Decided
Nov 13, 2006
Review
47 days
Class
Class II
Product code
KWI
Recalls
14
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K062898Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KWI device

  1. #1 K260624 Arthrex Radial Head Replacement Systemscore 12.1 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 24, 2017Class IIZ-2665-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2673-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2675-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2672-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2674-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2666-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2671-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2669-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2668-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2663-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2670-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2664-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Oct 24, 2017Class IIZ-2667-2018Under Investigation by firmRevision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Sep 6, 2013Class IIZ-0098-2014Packaging change controlThe recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.

The 5 latest of 14 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KWI devices

KWI Prosthesis, Elbow, Hemi-, Radial, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWI

1in 2024

2010: 12012: 12013: 12014: 12017: 12019: 12020: 12021: 12022: 12023: 12024: 12026 (partial year): 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWI

Too few KWI 510(k)s in any year since 2007 to give a median.

Recalls per year · KWI

2in 2022

2013: 12014: 12017: 12022: 2
2007high 2 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWI

118in 2025

2007: 152008: 162009: 142010: 132011: 102012: 162013: 312014: 292015: 1032016: 1382017: 3602018: 2022019: 2142020: 1182021: 442022: 442023: 772024: 1242025: 118
2007high 360 (2017) · low 10 (2011)2025

MAUDE reports naming product code KWI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—015
20080—016
20090—014
20101—013
20110—010
20121—016
20131—131
20141—129
20150—0103
20160—0138
20171—1360
20180—0202
20191—0214
20201—0118
20211—044
20221—244
20231—077
20241—0124
20250—0118
20261—0—

What is it indicated for?

The SBi Lateral Assembly rHead is intended for replacement of the proximal end of the radius:

1. Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:

a. Joint destruction or subluxation visible on x-ray

b. Resistance to conservative treatment

2. Primary replacement after fracture of the radial head

3. Symptomatic sequelae after radial head resection

Indications for use as stated in the FDA summary.

More from Small Bone Innovations, Inc.

20 FDA decisions under this applicant name. See the company

  • K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc. · 2013
  • K112982Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc. · 2012
  • K102180Rhead Radial Head Extended StemsSmall Bone Innovations, Inc. · 20109 recalls
  • K092754Sbi Foot and Ankle Cannulated Screw System, Model 100-0061Small Bone Innovations, Inc. · 2010
  • K093550Mini Rail External Fixator SystemSmall Bone Innovations, Inc. · 2010

Recent decisions in KWI

The KWI category page

  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026
  • K233592BioPoly Radial Head ImplantBioPoly, LLC · 2024
  • K231188ALIGN Radial Head SystemSkeletal Dynamics, Inc. · 2023
  • K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes · 2022
  • K212872Avenger Radial Head SystemIn2bones USA, LLC · 2021

https://510kreport.com/device/K062898 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062898: Sbi Lateral Rhead Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062898

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026