510(k) · Cleared
ClearedNeer Iii Total Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on May 23, 2000 after a 152-day review. The FDA summary names its predicate without a number.
- Decided
- May 23, 2000
- Review
- 152 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 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? (4)
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 |
|---|---|---|---|
| * | — | Neer II Total Shoulder System - 3M Named without a submission number | |
| * | — | Modular Total Shoulder System — 3M Named without a submission number | |
| * | — | Aequalis Shoulder System — Tornier S.A. Named without a submission number | |
| * | — | Neer II UHMWPE glenoid component Named without a submission number |
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.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Neer III Total Shoulder System is indicated for use as an orthopedic implant for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. The Neer III Total Shoulder System is intended for the following: Proximal Humeral Prosthesis - (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g., trauma - three and four-part…
Read the full statement (201 words)
The Neer III Total Shoulder System is indicated for use as an orthopedic implant for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively.
The Neer III Total Shoulder System is intended for the following:
Proximal Humeral Prosthesis - (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g., trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.
Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) — severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis,avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.
This device is intended only for cemented fixation.
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/K994350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994350: Neer Iii Total 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/K994350
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026