510(k) Report

510(k) · Cleared

Cleared

Suface Replacement Elbow

K820957510(k) TraditionalCleared Jul 2, 198287-day reviewClass II21 CFR 888.3160

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

Howmedica Corp. · JDB Prosthesis, Elbow, Semi-Constrained, Cemented

Cleared on Jul 2, 1982 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jul 2, 1982
Review
87 days
Class
Class II
Product code
JDB
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1999: 1 descendant cleared19801990200020102020
  1. This deviceK820957 Suface Replacement ElbowHowmedica Corp. · 1982
  2. Descendant · cites it directly · 1 of its ownK972691 Abc Total Elbow ProthesisBiomet, Inc. · 1997
  3. Descendant · 2 generations on · 0 of its ownK983036 Single Axle Total ElbowBiomet, Inc. · 1999

Most influential descendants

Showing 2 of 2 · See all
  • K972691Abc Total Elbow ProthesisBiomet, Inc. · 1997 · cites it directly1descendant
  • K983036Single Axle Total ElbowBiomet, Inc. · 1999 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K820957Suface Replacement ElbowHowmedica Corp.1982—
+1K972691Abc Total Elbow ProthesisBiomet, Inc.1997—
+2K983036Single Axle Total ElbowBiomet, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
FIG. 1 — Lineage of K820957, 1982–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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

Planning a device in JDB? 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 JDB device

  1. #1 K222807 TEMA Elbow system - Line extensionscore 4.0 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972691Abc Total Elbow ProthesisBiomet, Inc.19971

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?

  • Of its descendants, K972691 (Biomet, Inc., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JDB devices

JDB Prosthesis, Elbow, Semi-Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDB

1in 2022

2007: 22010: 22017: 12018: 12020: 12022: 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDB

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

Recalls per year · JDB

1in 2024

2011: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · JDB

38in 2025

2007: 32008: 132009: 102010: 72011: 62012: 62013: 22014: 52015: 442016: 112017: 262018: 392019: 312020: 322021: 232022: 582023: 292024: 1632025: 38
2007high 163 (2024) · low 2 (2013)2025

MAUDE reports naming product code JDB, 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
20072—03
20080—013
20090—010
20102—07
20110—16
20120—06
20130—02
20140—05
20150—044
20160—011
20171—026
20181—039
20190—031
20201—032
20210—023
20221—058
20230—029
20240—1163
20250—038
20260—0—

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

Recent decisions in JDB

The JDB category page

  • K222807TEMA Elbow system - Line extensionLima Corporate S.P.A. · 20221 recall
  • K193247LATITUDE EV™ Total Elbow ArthroplastyTornier, Inc. · 2020
  • K182461LATITUDE EV Total Elbow ArthroplastyTornier, Inc. · 2018
  • K171010Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017
  • K102180Rhead Radial Head Extended StemsSmall Bone Innovations, Inc. · 20109 recalls

https://510kreport.com/device/K820957 · printed Nov 6, 2026

Cite this page

510(k) Report. “K820957: Suface Replacement Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820957

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026