510(k) · Cleared

Recalled · Class II · 2014

Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System

K023096510(k) TraditionalCleared Apr 10, 2003204-day reviewClass II21 CFR 888.3690Recalls 5

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

Std Mfg., Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Apr 10, 2003 as substantially equivalent to K003044 (Biomet, Inc., 2000) and 2 other predicates after a 204-day review. Its family tree reaches back 2 generations to 2000. 10 later devices descend from it. It has been recalled 5 times.

Decided: Apr 10, 2003
Review: 204 days
Class: Class II
Product code: HSD
Recalls: 5
Predicates: 3

Its longest line of descent runs back 2 generations to K003044 (2000). 3 ancestors in all, the oldest K992394 (1999). 10 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK003044 Copeland Resurfacing HeadsBiomet, Inc. · 2000
1 generation backK010664 Copeland Resurfacing Humeral HeadsBiomet Manufacturing, Inc. · 2001
This deviceK023096 Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc. · 2003
Descendant · cites it directly · 8 of its ownK131298 Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc. · 2013
Descendant · cites it directly · 7 of its ownK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
Descendant · 2 generations on · 3 of its ownK181287 Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018
Descendant · 2 generations on · 2 of its ownK182500 Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc. · 2019
Descendant · 3 generations on · 1 of its ownK222317 Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc. · 2022

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2013high 3 (2018) · low 0 (2015)2026

Most influential descendants

Showing 5 of 10 · See all

K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc. · 2013 · cites it directly8descendants
K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016 · cites it directly7descendants
K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018 · 2 generations on3descendants
K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc. · 2019 · 2 generations on2descendants
K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc. · 2022 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003044	Copeland Resurfacing Heads	Biomet, Inc.	2000	—
−1	K010664	Copeland Resurfacing Humeral Heads	Biomet Manufacturing, Inc.	2001	—
0 (this device)	K023096	Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System	Std Mfg., Inc.	2003	—
+1	K131298	Exactech Equinoxe Resurfacing Humeral Head System	Exactech, Inc.	2013	—
+1	K152825	Catalyst CSR Shoulder System	Catalyst Orthoscience, LLC	2016	—
+2	K181287	Catalyst CSR Shoulder System	Catalyst Orthoscience, Inc.	2018	—
+2	K182500	Catalyst CSR Press-Fit Humeral Components	Catalyst Orthoscience, Inc.	2019	—
+3	K222317	Catalyst EA Convertible Stemmed Shoulder	Catalyst Orthoscience, Inc.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0
2016	1	0
2018	3	0
2019	2	0
2022	1	0
2025	1	0

FIG. 1 — Lineage of K023096, 2000–2025Source: 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 HSD? 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 HSD device

#1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K003044	Copeland Resurfacing Heads Summary page 3 …ded use, materials, and application of the candidate device are substantially equivalent to those of the following predicate devices: Copeland Resurfacing Heads (K003044, KO10664) Buechel-Pappas Humeral Head Resurfacing Component (K992394) Potential risks associated with the candidate devic…	Biomet, Inc.	2000	—
*	K010664	Copeland Resurfacing Humeral Heads	Biomet Manufacturing, Inc.	2001	—
*	K992394	Buechel-Pappas Humeral Head Resurfacing Component Summary page 3 …y equivalent to those of the following predicate devices: Copeland Resurfacing Heads (K003044, KO10664) Buechel-Pappas Humeral Head Resurfacing Component (K992394) Potential risks associated with the candidate device are the same as with other joint prosthetic devices. These include, but ar…	Endotec, Inc.	1999	—

Also cleared against K003044: 6 other devices →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K131298	Exactech Equinoxe Resurfacing Humeral Head System	Exactech, Inc.	2013	8
K152825	Catalyst CSR Shoulder System	Catalyst Orthoscience, LLC	2016	7
K142942	HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System	Arthrosurface, Inc.	2014	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 24, 2014	Class II	Z-1112-2015	No Marketing Application	Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Nov 24, 2014	Class II	Z-1114-2015	No Marketing Application	Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Nov 24, 2014	Class II	Z-1113-2015	No Marketing Application	Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Nov 24, 2014	Class II	Z-1111-2015	No Marketing Application	Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Nov 24, 2014	Class II	Z-1110-2015	No Marketing Application	Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K131298 (Exactech, Inc., 2013) has gone furthest, with 8 descendants of its own.
6 other devices also cite its predicate K003044.

How does its category compare?

All HSD devices

HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSD

1in 2024

2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSD

145in 2016

2007high 218 (2013) · low 72 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSD

1in 2020

2007high 3 (2017) · low 0 (2007)2026

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

Adverse event reports per year · HSD

757in 2025

2007high 985 (2017) · low 128 (2007)2025

MAUDE reports naming product code HSD, 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	4	72	0	128
2008	3	92	2	259
2009	0	—	2	156
2010	0	—	0	225
2011	2	—	0	241
2012	2	—	0	254
2013	4	218	0	288
2014	1	—	0	434
2015	0	—	0	574
2016	3	145	0	784
2017	0	—	3	985
2018	1	—	1	649
2019	0	—	0	830
2020	2	—	1	658
2021	0	—	0	573
2022	1	—	0	508
2023	0	—	0	586
2024	1	—	0	693
2025	0	—	0	757
2026	0	—	0	—

What is it indicated for?

For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023096 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023096: Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023096

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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