510(k) · Cleared
ClearedVaporized Hydrogen Peroxide (VHP) Sterilization of Unmwpe Components in the Cofield Total Shoulder System, the Neer II
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 Mar 15, 2002 after a 207-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Mar 15, 2002
- Review
- 207 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK012788 Vaporized Hydrogen Peroxide (VHP) Sterilization of Unmwpe Components…Smith & Nephew, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK053338 Arthrex Titanium and Bio-Degradable (Polymer) ImplantsArthrex, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053338Arthrex Titanium and Bio-Degradable (Polymer) ImplantsArthrex, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012788 | Vaporized Hydrogen Peroxide (VHP) Sterilization of Unmwpe Components in the… | Smith & Nephew, Inc. | 2002 | — |
| +1 | K053338 | Arthrex Titanium and Bio-Degradable (Polymer) Implants | Arthrex, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 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? (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 |
|---|---|---|---|
| * | — | Cofield Total Shoulder System Named without a submission number | |
| * | — | Neer II Total Shoulder System Named without a submission number | |
| * | — | Neer III Total Shoulder System Named without a submission number |
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 |
|---|---|---|---|
| K053338 | Arthrex Titanium and Bio-Degradable (Polymer) Implants | 2006 | 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?
- Of its descendants, K053338 (Arthrex, Inc., 2006) has gone furthest, with 0 descendants of its own.
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 Cofield® Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are indicated for use as orthopaedic implants 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 Cofield® Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are intended for the…
Read the full statement (293 words)
The Cofield® Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are indicated for use as orthopaedic implants 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 Cofield® Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are 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. The subject all poly glenoid components are intended for cemented fixation only and for single use only.
The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all polyethylene glenoid components manufactured from UHMWPE material in the following product systems:
o Cofield’ Total Shoulder System (all polyethylene glenoid components)
e Neer II Total Shoulder System (all polyethylene glenoid components)
e Neer III Total Shoulder System (all polyethylene glenoid components)
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/K012788 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012788: Vaporized Hydrogen Peroxide (VHP) Sterilization of Unmwpe Components in the Cofield Total Shoulder System, the Neer II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012788
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026