510(k) · Cleared

Cleared

Abc Total Elbow Prothesis

K972691510(k) TraditionalCleared Oct 15, 199790-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

Biomet, Inc. · JDB Prosthesis, Elbow, Semi-Constrained, Cemented

Cleared on Oct 15, 1997 as substantially equivalent to K955099 (Wrightmedicaltechnologyinc, 1996) and 4 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it.

Decided: Oct 15, 1997
Review: 90 days
Class: Class II
Product code: JDB
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K810847 (1981). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK810847 Pritchard Surface Replacement ElbowDepuy, Inc. · 1981
This deviceK972691 Abc Total Elbow ProthesisBiomet, Inc. · 1997
Descendant · cites it directly · 0 of its ownK983036 Single Axle Total ElbowBiomet, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K983036Single Axle Total ElbowBiomet, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K810847	Pritchard Surface Replacement Elbow	Depuy, Inc.	1981	—
0 (this device)	K972691	Abc Total Elbow Prothesis	Biomet, Inc.	1997	—
+1	K983036	Single Axle Total Elbow	Biomet, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1986	1	0
1989	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K972691, 1981–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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 K222807 TEMA Elbow system - Line extensionscore 4.0 · 7 generations · no Class I recall
#2 Held for the reportin the report

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What was it cleared against? (6)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K955099	Sorbie Total Elbow System Summary page 2 …almost all elbow devices on the market in overall design and intended function. Predicate devices include: - Sorbie-Questor Total Elbow System (Wright Medical, 510(k) # K955099) Osteonics Elbow Prothesis (Osteonics, 510(k) #K861680) Coonrad lll Total Elbow (Zimmer, 510(k) #K883665) Pritchard Elbow (Depu…	Wrightmedicaltechnologyinc	1996	—
*	K861680	Osteonics Elbow Prosthesis Summary page 2 …n and intended function. Predicate devices include: - Sorbie-Questor Total Elbow System (Wright Medical, 510(k) # K955099) Osteonics Elbow Prothesis (Osteonics, 510(k) #K861680) Coonrad lll Total Elbow (Zimmer, 510(k) #K883665) Pritchard Elbow (Depuy, 510(k) #K810847) Surface Replacement Elbow (Howmedi…	Osteonics Corp.	1986	—
*	K883665	Coonrad Iii Total Elbow Summary page 2 …- Sorbie-Questor Total Elbow System (Wright Medical, 510(k) # K955099) Osteonics Elbow Prothesis (Osteonics, 510(k) #K861680) Coonrad lll Total Elbow (Zimmer, 510(k) #K883665) Pritchard Elbow (Depuy, 510(k) #K810847) Surface Replacement Elbow (Howmedica, 510(k) # K820957) Capitello Condylar (Johnson…	Zimmer, Inc.	1989	—
*	K810847	Pritchard Surface Replacement Elbow Summary page 2 …ght Medical, 510(k) # K955099) Osteonics Elbow Prothesis (Osteonics, 510(k) #K861680) Coonrad lll Total Elbow (Zimmer, 510(k) #K883665) Pritchard Elbow (Depuy, 510(k) #K810847) Surface Replacement Elbow (Howmedica, 510(k) # K820957) Capitello Condylar (Johnson & Johnson, Preamendment?)…	Depuy, Inc.	1981	—
*	K820957	Suface Replacement Elbow Summary page 2 …(Osteonics, 510(k) #K861680) Coonrad lll Total Elbow (Zimmer, 510(k) #K883665) Pritchard Elbow (Depuy, 510(k) #K810847) Surface Replacement Elbow (Howmedica, 510(k) # K820957) Capitello Condylar (Johnson & Johnson, Preamendment?) “%, HEALT) «0‘ h“/ 4 £/ % lm ERVICE, 5 S L) C DEPA…	Howmedica Corp.	1982	—
*	—	Capitello Condylar Named without a submission number			—

Also cleared against K955099: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K983036	Single Axle Total Elbow	Biomet, Inc.	1999	0

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?

None of the 5 ancestors has a recall.
Of its descendants, K983036 (Biomet, Inc., 1999) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K955099.

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

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	3
2008	0	—	0	13
2009	0	—	0	10
2010	2	—	0	7
2011	0	—	1	6
2012	0	—	0	6
2013	0	—	0	2
2014	0	—	0	5
2015	0	—	0	44
2016	0	—	0	11
2017	1	—	0	26
2018	1	—	0	39
2019	0	—	0	31
2020	1	—	0	32
2021	0	—	0	23
2022	1	—	0	58
2023	0	—	0	29
2024	0	—	1	163
2025	0	—	0	38
2026	0	—	0	—

What is it indicated for?

The ABC Elbow Prothesis is indicated for use in Rheumatoid Arthritis, Non-Inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods.

This device is a single use implant. It is intended for use with bone cement.

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

https://510kreport.com/device/K972691 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972691: Abc Total Elbow Prothesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972691

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026