510(k) · Cleared
ClearedAxiom Orthopaedics Shoulder Resurfacing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axiom Orthopaedics, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Aug 28, 2006 as substantially equivalent to K033516 (DePuy Orthopaedics, Inc., 2003) and 1 other predicate after a 59-day review. Its family tree reaches back 6 generations to 1980. 121 later devices descend from it.
- Decided
- Aug 28, 2006
- Review
- 59 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K800494 (1980). 11 ancestors in all. 121 later devices descend from it, 1 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 backK033516 Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc. · 2003
- This deviceK061862 Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 120 of its ownK071147 Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007
- Descendant · 2 generations on · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
- Descendant · 3 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 2 generations on · 105 of its ownK113413 Ascend Shoulder SystemTornier, Inc. · 2012
- Descendant · 3 generations on · 98 of its ownK120794 Ascend Shoulder SystemTornier, Inc. · 2012
Showing 5 of 121 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 121 · See all- K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007 · cites it directly120descendants
- K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · 2 generations on110descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on108descendants
- K113413Ascend Shoulder SystemTornier, Inc. · 2012 · 2 generations on105descendants
- K120794Ascend Shoulder SystemTornier, Inc. · 2012 · 3 generations on98descendants
View 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 | K033516 | Depuy Global Cap HA Resurfacing Shoulder Humeral Heads | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K061862 | Axiom Orthopaedics Shoulder Resurfacing System | Axiom Orthopaedics, Inc. | 2006 | — |
| +1 | K071147 | Nexa Orthopedics Total Shoulder System | Nexa Orthopedics, Inc. | 2007 | — |
| +2 | K102924 | Aequalis Ascend Modular Anatomic Shoulder System | Tornier, Inc. | 2011 | — |
| +3 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +2 | K113413 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
| +3 | K120794 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 11 | 0 |
| 2021 | 10 | 0 |
| 2022 | 15 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 13 | 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? (2)
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 |
|---|---|---|---|
| * | K033516 | Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsSummary page 1…oulder), metallic uncemente& prosthesis 3. PREDICATE DEVICES Depuy Global CAP Resurfacing Repl[icement Shoulder K033516 Biomet Copeland Resurfacing Humeral Heads K010657 4. DEVICE DESCRIPTION The Axiom Orthopa… | 2003 |
| * | K010657 | Copeland MB Resurfacing Humeral HeadsSummary page 1…PREDICATE DEVICES Depuy Global CAP Resurfacing Repl[icement Shoulder K033516 Biomet Copeland Resurfacing Humeral Heads K010657 4. DEVICE DESCRIPTION The Axiom Orthopaedics Shoulder Rcsurfacing System is a series of humeral heads that are… | 2001 |
What descends from it? (121)
See all 1211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071147 | Nexa Orthopedics Total Shoulder System | 2007 | 120 |
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 26 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K071147 (Nexa Orthopedics, Inc., 2007) has gone furthest, with 120 descendants of its own.
- 3 other devices also cite its predicate K033516.
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 Axiom Orthopaedics Shoulder Resurfacing System is intended as a hemi shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device will increase shoulder mobility by reducing pain, restoring alignment, restoring flexion and extension movement, and resisting dislocation. The Axiom Orthopaedics Shoulder Resurfacing System is indicated for use as a replacement…
Read the full statement (112 words)
The Axiom Orthopaedics Shoulder Resurfacing System is intended as a hemi shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device will increase shoulder mobility by reducing pain, restoring alignment, restoring flexion and extension movement, and resisting dislocation.
The Axiom Orthopaedics Shoulder Resurfacing System is indicated for use as a replacement of shoulder joints disabled by
1. Rheumatoid arthritis with pain
2. Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
3. Correction of functional deformity
4. Fractures of the humeral head
5. Traumatic arthritis.
These components are single use only and are intended for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061862: Axiom Orthopaedics Shoulder 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/K061862
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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