510(k) · Cleared
Recalled · Class III · 2018Ascension Humeral Resurfacing Arthroplasty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Oct 31, 2006 as substantially equivalent to K010664 (Biomet Manufacturing, Inc., 2001) and 2 other predicates after a 36-day review. Its family tree reaches back 6 generations to 1980. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 31, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- HSD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K800494 (1980). 23 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 5 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 4 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 3 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
- 2 generations backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
- 1 generation backK051843 Copeland Eas Humeral Resurfacing HeadsBiomet, Inc. · 2005 · Recalled
- This deviceK062861 Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK213827 TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System…Smith & Nephew, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK071064 Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −5 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −4 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −3 | K010827 | Copeland MB/HA Resurfacing Humeral Heads | Biomet Orthopedics, Inc. | 2001 | 1 |
| −2 | K031971 | Global Cap Resurfacing Replacement Shoulder | DePuy Orthopaedics, Inc. | 2003 | — |
| −1 | K051843 | Copeland Eas Humeral Resurfacing Heads | Biomet, Inc. | 2005 | 1 |
| 0 (this device) | K062861 | Ascension Humeral Resurfacing Arthroplasty System | Ascension Orthopedics, Inc. | 2006 | — |
| +1 | K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN… | Smith & Nephew, Inc. | 2022 | — |
| +1 | K071064 | Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HA | Ascension Orthopedics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2022 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K010664 | Copeland Resurfacing Humeral HeadsSummary page 2…Head.P. Arthroplasty (HRA) Device FDA 510(k) clearance K010664, and K031971 K051843 Use… | 2001 |
| * | K051843 | Copeland Eas Humeral Resurfacing HeadsSummary page 2…Device FDA 510(k) clearance K010664, and K031971 K051843 Use Single use Single use Single use Implantation duration… | 2005 |
| * | K031971 | Global Cap Resurfacing Replacement ShoulderSummary page 1…HSD PANEL: Orthopedic PREDICATE DEVICES: Biomet Copeland Humeral Resurfacing Head (KO 10664, and KO051843) DePuy Global C.A.P. (K03 1971) DEVICE DESCRIPTION: The Ascension® HRA® System includes an anatomically designed, semi-constrained, monolithic device designed… | 2003 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 16, 2018 | Class III | Z-0794-2019 | Vendor change control | The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K213827 (Smith & Nephew, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K010664.
How does its category compare?
All HSD devicesHSD 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
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 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?
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.
* Malunions of the humeral head.
* Acute fractures of the humeral head
* Patients with an intact or reparable rotator cuff.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062861 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062861: Ascension Humeral Resurfacing Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062861
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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