510(k) Report

510(k) · Cleared

Cleared

HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System

K142942510(k) SpecialCleared Dec 19, 201466-day reviewClass II21 CFR 888.3690

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

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

Cleared on Dec 19, 2014 as substantially equivalent to K023096 (Std Mfg., Inc., 2003) and 3 other predicates after a 66-day review. Its family tree reaches back 5 generations to 1980. 1 later device descends from it.

Decided
Dec 19, 2014
Review
66 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K800494 (1980). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1999: 2 other ancestors1991: 1 other ancestor1980: 1 other ancestor2018: 1 descendant clearedK800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980K991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK010827 · Copeland MB/HA Resurfacing Humeral Heads · Biomet Orthopedics, Inc. · 2001 · recalledK031971 · Global Cap Resurfacing Replacement Shoulder · DePuy Orthopaedics, Inc. · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 1 descendant K031971 · Global Cap Resurfacing Replacement Shoulder · DePuy Orthopaedics, Inc. · 2003K010827 · Copeland MB/HA Resurfacing Humeral Heads · Biomet Orthopedics, Inc. · 2001 · recalledK002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980−50
  1. Root · 5 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
  2. 4 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
  3. 3 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
  4. 2 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
  5. 1 generation backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
  6. This deviceK142942 HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc. · 2014
  7. Descendant · cites it directly · 0 of its ownK173964 OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K800494New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc.1980—
−4K991585Bipolar Shoulder ProsthesisBiomet, Inc.1999—
−3K002998Biomet BI-Polar Shoulder SystemBiomet, Inc.20001
−2K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc.20011
−1K031971Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc.2003—
0 (this device)K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc.2014—
+1K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199110
199920
200010
200110
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K142942, 1980–2018Source: 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 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. #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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
*K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System
Summary page 5
…devices, which have been previously cleared by the FDA: x The sponsor’s previously cleared Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System (K023096, Cleared on 04/10/2003) x Biomet Inc.’s Copeland Resurfacing Heads (K003044, Cleared on 12/13/2000 and K010664, Cleared on…
Std Mfg., Inc.20035
*K003044Copeland Resurfacing Heads
Summary page 5
…reviously cleared Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System (K023096, Cleared on 04/10/2003) x Biomet Inc.’s Copeland Resurfacing Heads (K003044, Cleared on 12/13/2000 and K010664, Cleared on 04/05/2001) x DePuy Orthopaedics Inc.’s Global CAP Resurfacing Replacement S…
Biomet, Inc.2000—
*K010664Copeland Resurfacing Humeral Heads
Summary page 5
…rosthetic (CAP) Humeral Head Resurfacing System (K023096, Cleared on 04/10/2003) x Biomet Inc.’s Copeland Resurfacing Heads (K003044, Cleared on 12/13/2000 and K010664, Cleared on 04/05/2001) x DePuy Orthopaedics Inc.’s Global CAP Resurfacing Replacement Shoulder (K031971, Cleared on 09/24/…
Biomet Manufacturing, Inc.2001—
*K031971Global Cap Resurfacing Replacement Shoulder
Summary page 5
…Resurfacing Heads (K003044, Cleared on 12/13/2000 and K010664, Cleared on 04/05/2001) x DePuy Orthopaedics Inc.’s Global CAP Resurfacing Replacement Shoulder (K031971, Cleared on 09/24/2003) The fundamental scientific technology of the proposed device has not changed relative to the predicate…
DePuy Orthopaedics, Inc.2003—

Also cleared against K023096: 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.

NumberDeviceApplicantDecidedDescendants
K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180

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 34 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
  • 4 of the 12 ancestors have a recall of any class.
  • Of its descendants, K173964 (Arthrosurface, Inc., 2018) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K023096.

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. 2014, this device’s year, is highlighted.

FDA decisions per year · HSD

1in 2024

2007: 42008: 32011: 22012: 22013: 42014: 12016: 32018: 12020: 22022: 12024: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSD

145in 2016

2007: 72 days median2008: 92 days median2013: 218 days median2016: 145 days median
2007high 218 (2013) · low 72 (2007)2026

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

Recalls per year · HSD

1in 2020

2008: 22009: 22017: 32018: 12020: 1
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

2007: 1282008: 2592009: 1562010: 2252011: 2412012: 2542013: 2882014: 4342015: 5742016: 7842017: 9852018: 6492019: 8302020: 6582021: 5732022: 5082023: 5862024: 6932025: 757
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074720128
20083922259
20090—2156
20100—0225
20112—0241
20122—0254
201342180288
20141—0434
20150—0574
201631450784
20170—3985
20181—1649
20190—0830
20202—1658
20210—0573
20221—0508
20230—0586
20241—0693
20250—0757
20260—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.

Also cleared against K023096

2 other devices cite the same predicate.

  • K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
  • K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc. · 2013

More from Arthrosurface, Inc.

26 FDA decisions under this applicant name. See the company

  • K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc. · 2021
  • K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020
  • K190261BOSS Toe Fixation SystemArthrosurface, Inc. · 2019
  • K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. · 20183 recalls
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

Recent decisions in HSD

The HSD category page

  • K233260Univers Revers CA Head and AdapterArthrex, Inc. · 2024
  • K221232Univers Revers Humeral Cup ImplantArthrex, Inc. · 2022
  • K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
  • K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC · 2020
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

https://510kreport.com/device/K142942 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142942: HemiCAP Humeral Head XL (HHXL) Articular 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/K142942

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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