510(k) Report

510(k) · Cleared

Cleared

Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HA

K071064510(k) TraditionalCleared Jun 22, 200767-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

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

Cleared on Jun 22, 2007 as substantially equivalent to K010664 (Biomet Manufacturing, Inc., 2001) and 5 other predicates after a 67-day review. Its family tree reaches back 7 generations to 1980.

Decided
Jun 22, 2007
Review
67 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
6

Its longest line of descent runs back 7 generations to K800494 (1980). 25 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 2 other ancestors2001: 3 other ancestors2000: 2 other ancestors1999: 2 other ancestors1991: 1 other ancestor1998: 2 other ancestors1994: 1 other ancestor1992: 2 other ancestors1987: 1 other ancestor1980: 1 other ancestor1995: 1 other ancestorK800494 · 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. · 2003K051843 · Copeland Eas Humeral Resurfacing Heads · Biomet, Inc. · 2005 · recalledK062861 · Ascension Humeral Resurfacing Arthroplasty System · Ascension Orthopedics, Inc. · 2006 · recalled198019851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 9 other ancestors4 generations back: 1 other ancestor K062861 · Ascension Humeral Resurfacing Arthroplasty System · Ascension Orthopedics, Inc. · 2006 · recalledK051843 · Copeland Eas Humeral Resurfacing Heads · Biomet, Inc. · 2005 · recalledK031971 · 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 · 7 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
  2. 6 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
  3. 5 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
  4. 4 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
  5. 3 generations backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
  6. 2 generations backK051843 Copeland Eas Humeral Resurfacing HeadsBiomet, Inc. · 2005 · Recalled
  7. 1 generation backK062861 Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc. · 2006 · Recalled
  8. This deviceK071064 Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K800494New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc.1980—
−6K991585Bipolar Shoulder ProsthesisBiomet, Inc.1999—
−5K002998Biomet BI-Polar Shoulder SystemBiomet, Inc.20001
−4K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc.20011
−3K031971Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc.2003—
−2K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc.20051
−1K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc.20061
0 (this device)K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198710
199110
199220
199410
199510
199820
199920
200020
200130
200320
FIG. 1 — Lineage of K071064, 1980–2007Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K010664Copeland Resurfacing Humeral Heads
Summary page 1
…21 CFR 888.3690 PRODUCT CODE: HSD PANEL: Orthopedic PREDICATE DEVICES: Biomet Copeland Humeral Resurfacing Head (K010664, K010827 and K051843) DePuy Global C.A.P. (K031971 and K033516) Ascension® Humeral Resurfacing Arthroplasty (HRA) System (K062861…
Biomet Manufacturing, Inc.2001—
*K010827Copeland MB/HA Resurfacing Humeral Heads
Summary page 1
…21 CFR 888.3690 PRODUCT CODE: HSD PANEL: Orthopedic PREDICATE DEVICES: Biomet Copeland Humeral Resurfacing Head (K010664, K010827 and K051843) DePuy Global C.A.P. (K031971 and K033516) Ascension® Humeral Resurfacing Arthroplasty (HRA) System (K062861) DEVICE…
Biomet Orthopedics, Inc.20011
*K051843Copeland Eas Humeral Resurfacing Heads
Summary page 1
…88.3690 PRODUCT CODE: HSD PANEL: Orthopedic PREDICATE DEVICES: Biomet Copeland Humeral Resurfacing Head (K010664, K010827 and K051843) DePuy Global C.A.P. (K031971 and K033516) Ascension® Humeral Resurfacing Arthroplasty (HRA) System (K062861) DEVICE DESCRIPTION…
Biomet, Inc.20051
*K031971Global Cap Resurfacing Replacement Shoulder
Summary page 1
…HSD PANEL: Orthopedic PREDICATE DEVICES: Biomet Copeland Humeral Resurfacing Head (K010664, K010827 and K051843) DePuy Global C.A.P. (K031971 and K033516) Ascension® Humeral Resurfacing Arthroplasty (HRA) System (K062861) DEVICE DESCRIPTION: The Ascension® HRA® System T…
DePuy Orthopaedics, Inc.2003—
*K033516Depuy Global Cap HA Resurfacing Shoulder Humeral Heads
Summary page 1
…D PANEL: Orthopedic PREDICATE DEVICES: Biomet Copeland Humeral Resurfacing Head (K010664, K010827 and K051843) DePuy Global C.A.P. (K031971 and K033516) Ascension® Humeral Resurfacing Arthroplasty (HRA) System (K062861) DEVICE DESCRIPTION: The Ascension® HRA® System TPS/HA includ…
DePuy Orthopaedics, Inc.2003—
*K062861Ascension Humeral Resurfacing Arthroplasty System
Summary page 1
…omet Copeland Humeral Resurfacing Head (K010664, K010827 and K051843) DePuy Global C.A.P. (K031971 and K033516) Ascension® Humeral Resurfacing Arthroplasty (HRA) System (K062861) DEVICE DESCRIPTION: The Ascension® HRA® System TPS/HA includes an anatomically designed, semi-constrained, monolithic device de…
Ascension Orthopedics, Inc.20061

Also cleared against K010664: 3 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 27 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
  • 6 of the 25 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K010664.

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. 2007, 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?

The Ascension® HRA® device is intended for resurfacing of the humeral head due to:

Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis).

Mild or moderate humeral head deformity and / or limited motion.

Post-traumatic arthritis.

Patients with an intact or reparable rotator cuff.

Indications for use as stated in the FDA summary.

Also cleared against K010664

3 other devices cite the same predicate.

  • K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc. · 2014
  • K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc. · 20061 recall
  • K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc. · 20035 recalls

More from Ascension Orthopedics, Inc.

22 FDA decisions under this applicant name. See the company

  • K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024
  • K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. · 2023
  • K121826Integra Proximal Humeral Plate SystemAscension Orthopedics, Inc. · 2013
  • K110700Ascension Atlas Humeral Plating SystemAscension Orthopedics, Inc. · 2011
  • K102549The Ascension Movement Great Toe System Total ArthroplastyAscension Orthopedics, Inc. · 2010

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/K071064 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071064: Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071064

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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