510(k) · Cleared
ClearedNexa Orthopedics Total Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexa Orthopedics, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Jul 20, 2007 as substantially equivalent to K992119 (Biomet, Inc., 1999) and 5 other predicates after an 87-day review. Its family tree reaches back 7 generations to 1980. 120 later devices descend from it.
- Decided
- Jul 20, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K800494 (1980). 41 ancestors in all. 120 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 6 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 5 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 4 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
- 3 generations backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
- 2 generations backK033516 Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc. · 2003
- 1 generation backK061862 Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006
- This deviceK071147 Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007
- Descendant · cites it directly · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
- Descendant · 2 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · cites it directly · 105 of its ownK113413 Ascend Shoulder SystemTornier, Inc. · 2012
- Descendant · 2 generations on · 98 of its ownK120794 Ascend Shoulder SystemTornier, Inc. · 2012
- Descendant · 3 generations on · 97 of its ownK121493 Ascend Shoulder SystemTornier, Inc. · 2012
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · cites it directly110descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on108descendants
- K113413Ascend Shoulder SystemTornier, Inc. · 2012 · cites it directly105descendants
- K120794Ascend Shoulder SystemTornier, Inc. · 2012 · 2 generations on98descendants
- K121493Ascend Shoulder SystemTornier, Inc. · 2012 · 3 generations on97descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −6 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −5 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −4 | K010827 | Copeland MB/HA Resurfacing Humeral Heads | Biomet Orthopedics, Inc. | 2001 | 1 |
| −3 | K031971 | Global Cap Resurfacing Replacement Shoulder | DePuy Orthopaedics, Inc. | 2003 | — |
| −2 | K033516 | Depuy Global Cap HA Resurfacing Shoulder Humeral Heads | DePuy Orthopaedics, Inc. | 2003 | — |
| −1 | K061862 | Axiom Orthopaedics Shoulder Resurfacing System | Axiom Orthopaedics, Inc. | 2006 | — |
| 0 (this device) | K071147 | Nexa Orthopedics Total Shoulder System | Nexa Orthopedics, Inc. | 2007 | — |
| +1 | K102924 | Aequalis Ascend Modular Anatomic Shoulder System | Tornier, Inc. | 2011 | — |
| +2 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +1 | K113413 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
| +2 | K120794 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
| +3 | K121493 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KWT? 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992119 | Bio-Modular Shoulder SystemSummary page 1…eral (hemi-shoulder) metallic uncemented prosthesis. 3. PREDICATE DEVICES * Biomet Bio-Modular Shoulder System (K992119, K992899, K030710, K032507) * Tomier Aequalis Shoulder System (K063081) * Axiom Orthopaedics Shoulder… | 1999 |
| * | K992899 | Bio-Modular Shoulder Offset Humeral HeadsSummary page 1…(hemi-shoulder) metallic uncemented prosthesis. 3. PREDICATE DEVICES * Biomet Bio-Modular Shoulder System (K992119, K992899, K030710, K032507) * Tomier Aequalis Shoulder System (K063081) * Axiom Orthopaedics Shoulder Resurfaci… | 1999 |
| * | K030710 | Bio-Modular Shoulder SystemSummary page 1…metallic uncemented prosthesis. 3. PREDICATE DEVICES * Biomet Bio-Modular Shoulder System (K992119, K992899, K030710, K032507) * Tomier Aequalis Shoulder System (K063081) * Axiom Orthopaedics Shoulder Resurfacing System (K061862)… | 2003 |
| * | K032507 | Interlok Bio-Modular Humeral StemsSummary page 1…uncemented prosthesis. 3. PREDICATE DEVICES * Biomet Bio-Modular Shoulder System (K992119, K992899, K030710, K032507) * Tomier Aequalis Shoulder System (K063081) * Axiom Orthopaedics Shoulder Resurfacing System (K061862) Nexa Orthop… | 2003 |
| * | K063081 | Aequalis Shoulder SystemSummary page 1…3. PREDICATE DEVICES * Biomet Bio-Modular Shoulder System (K992119, K992899, K030710, K032507) * Tomier Aequalis Shoulder System (K063081) * Axiom Orthopaedics Shoulder Resurfacing System (K061862) Nexa Orthopedics 510(k) April 4, 2007 Tot… | 2006 |
| * | K061862 | Axiom Orthopaedics Shoulder Resurfacing SystemSummary page 1…lder System (K992119, K992899, K030710, K032507) * Tomier Aequalis Shoulder System (K063081) * Axiom Orthopaedics Shoulder Resurfacing System (K061862) Nexa Orthopedics 510(k) April 4, 2007 Total Shoulder System 4. DEVICE DESCRIPTION… | 2006 |
What descends from it? (120)
See all 1202 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)
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 6 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 41 ancestors have a recall of any class.
- Of its descendants, K102924 (Tornier, Inc., 2011) has gone furthest, with 110 descendants of its own.
- 12 other devices also cite its predicate K992119.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional all polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement shoulder system. The Nexa Total Shoulder System is to be used only inpatients with an intact or reconstructable rotator cuff, where…
Read the full statement (171 words)
The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional all polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement shoulder system. The Nexa Total Shoulder System is to be used only inpatients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.
The Nexa Orthopedics Total Shoulder System is indicated for use as a replacement of shoulder joints disabled by the following:
* Rheumatoid arthritis with pain
* Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
* Correction of functional deformity
* Fractures of the humeral head
* Traumatic arthritis
* Revision of other devices if sufficient bone stock remains
All components are single use. The humeral stem is intended for cemented or cementless use while the all polyethylene glenoid is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071147 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071147: Nexa Orthopedics Total Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071147
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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