510(k) Report

510(k) · Cleared

Cleared

Howmedica Osteonics Radial Head Prothesis

K001385510(k) TraditionalCleared Jul 27, 200086-day reviewClass II21 CFR 888.3170

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

Howmedica Osteonics Corp. · KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

Cleared on Jul 27, 2000 as substantially equivalent to K944507 (Wrightmedicaltechnologyinc, 1995) and 2 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1995.

Decided
Jul 27, 2000
Review
86 days
Class
Class II
Product code
KWI
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K944507 (1995). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestorK944507 · Metallic Radial Head Implants · Wrightmedicaltechnologyinc · 1995K982288 · Radial Head Implant · Avanta Orthopaedics, Inc. · 1998 · recalledK992220 · Radial Head Prosthesis · Smith & Nephew, Inc. · 20001996199820002002
Other ancestors, by generation 2 generations back: 1 other ancestor K992220 · Radial Head Prosthesis · Smith & Nephew, Inc. · 2000K982288 · Radial Head Implant · Avanta Orthopaedics, Inc. · 1998 · recalledK944507 · Metallic Radial Head Implants · Wrightmedicaltechnologyinc · 19950
  1. Root · 3 generations backK944507 Metallic Radial Head ImplantsWrightmedicaltechnologyinc · 1995
  2. 2 generations backK982288 Radial Head ImplantAvanta Orthopaedics, Inc. · 1998 · Recalled
  3. 1 generation backK992220 Radial Head ProsthesisSmith & Nephew, Inc. · 2000
  4. This deviceK001385 Howmedica Osteonics Radial Head ProthesisHowmedica Osteonics Corp. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K944507Metallic Radial Head ImplantsWrightmedicaltechnologyinc1995—
−2K982288Radial Head ImplantAvanta Orthopaedics, Inc.19981
−1K992220Radial Head ProsthesisSmith & Nephew, Inc.2000—
0 (this device)K001385Howmedica Osteonics Radial Head ProthesisHowmedica Osteonics Corp.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K001385, 1995–2000Source: FDA 510(k) summaries, read by 510(k) Report · 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? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K944507Metallic Radial Head Implants
Summary page 1
…stliesis'is based upon equivalence in intended use, materials, design, and operational principl&s to the Wright Medical Technology, Inc. Metallic Radial I-lead Implants (K944507), the Avanta Ortbopaedics, Inc Radial I lead Implant (K982288) and the Smith & Nephew, Inc. Radial Head Prosill6is (K992220).…
Wrightmedicaltechnologyinc1995—
*K982288Radial Head Implant
Summary page 1
…design, and operational principl&s to the Wright Medical Technology, Inc. Metallic Radial I-lead Implants (K944507), the Avanta Ortbopaedics, Inc Radial I lead Implant (K982288) and the Smith & Nephew, Inc. Radial Head Prosill6is (K992220). For information contact: Jennifer A. Daudelin…
Avanta Orthopaedics, Inc.19981
*K992220Radial Head Prosthesis
Summary page 1
…nology, Inc. Metallic Radial I-lead Implants (K944507), the Avanta Ortbopaedics, Inc Radial I lead Implant (K982288) and the Smith & Nephew, Inc. Radial Head Prosill6is (K992220). For information contact: Jennifer A. Daudelin Regulatory Affairs…
Smith & Nephew, Inc.2000—

Also cleared against K944507: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K944507.

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 Howmedica Osteonics Radial Head Prosthesis is indicated for replacement of the proximal end of the radius in cases of rheumatoid arthritis; degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion of the radio-humeral and/or proximal radio-ulnar joint involving joint destruction and/or subluxation visible on x-ray; resistance to conservative treatment; fracture of the radial head; and symptomatic sequela after radial head resection. It is also indicated for use in revision procedures following failed radial head arthroplasty. This device is intended for cemented use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K944507

2 other devices cite the same predicate.

  • K992220Radial Head ProsthesisSmith & Nephew, Inc. · 2000
  • K982288Radial Head ImplantAvanta Orthopaedics, Inc. · 19981 recall

More from Howmedica Osteonics Corp.

319 FDA decisions under this applicant name. See the company

  • P000013/S027Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® SystemHowmedica Osteonics Corp. · 2025
  • P000013/S026Trident Acetabular System: Trident Alumina InsertsHowmedica Osteonics Corp. · 2025
  • P000013/S025Trident® Acetabular SystemHowmedica Osteonics Corp. · 2024
  • P000013/S024Trident (R), ABC (R)Howmedica Osteonics Corp. · 2024
  • P000013/S021Trident Ceramic SystemHowmedica Osteonics Corp. · 2023

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/K001385 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001385: Howmedica Osteonics Radial Head Prothesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001385

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026