510(k) · Cleared
ClearedSMR Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Jun 24, 2016 as substantially equivalent to K100858 (Lima-Lto S.P.A., 2010) after a 28-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.
- Decided
- Jun 24, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K873073 (1987). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK873073 Kirschner Neer-Iii Proximal HumerusKirschner Medical Corp. · 1987
- 3 generations backK961260 Kirschner Sholders with Titanium Plasma SprayBiomet, Inc. · 1997
- 2 generations backK992525 Acumed Modular Shoulder SystemAcu Med, Inc. · 2000 · Recalled
- 1 generation backK100858 Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder…Lima-Lto S.P.A. · 2010 · Recalled
- This deviceK161476 SMR Shoulder SystemLima Corporate S.P.A. · 2016
- Descendant · cites it directly · 0 of its ownK210899 LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG · 2021
Most influential descendants
Showing 1 of 1 · See all- K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K873073 | Kirschner Neer-Iii Proximal Humerus | Kirschner Medical Corp. | 1987 | — |
| −3 | K961260 | Kirschner Sholders with Titanium Plasma Spray | Biomet, Inc. | 1997 | — |
| −2 | K992525 | Acumed Modular Shoulder System | Acu Med, Inc. | 2000 | 1 |
| −1 | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System -… | Lima-Lto S.P.A. | 2010 | 2 |
| 0 (this device) | K161476 | SMR Shoulder System | Lima Corporate S.P.A. | 2016 | — |
| +1 | K210899 | LINK Embrace Shoulder System- Anatomical Configuration | Waldemar Link GmbH & Co. KG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 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? (1)
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 |
|---|---|---|---|
| * | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Summary page 7…ral Heads with +2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric). Predicate Devices SMR Shoulder System (Limacorporate, K100858). Comparable Features to Predicate Device(s) The new heights of the Humeral Heads and the new Adaptor Taper of the SMR Shoulder… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210899 | LINK Embrace Shoulder System- Anatomical Configuration | 2021 | 0 |
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 29 years and passes through 5 companies; a new generation was cleared every 9.5 years on median.
- 6 of the 16 ancestors have a recall of any class.
- Of its descendants, K210899 (Waldemar Link GmbH & Co. KG, 2021) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K100858.
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. 2016, 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 SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Inflammatory degenerative joint disease such as rheumatoid arthritis; Treatment of acute fractures…
Read the full statement (502 words)
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
Inflammatory degenerative joint disease such as rheumatoid arthritis;
Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
Revision of a failed primary implant;
Cuff tear arthropathy (CTA Heads only).
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid construct consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented.
In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
The SMR TT Metal Back is indicated for primary implant in anatomic or reverse total shoulder arthroplasty with poor glenoid bone quality or in revision case with consistent bone loss on the glenoid side. The implant is suitable for implantation with or without bone graft. These indications are not yet approved in the US.
In the US the SMR TT Metal Back Baseplate used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws; while when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
The Dia. 50, 52 and 54 mm Humeral Heads with +3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric)
The Dia. 52 and 54 mm Humeral Heads with +2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161476: SMR Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161476
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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