510(k) · Cleared
ClearedGrit Blasted Humeral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Jun 29, 1999 after a 50-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 29, 1999
- Review
- 50 days
- Class
- Class II
- Product code
- KWT
- 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 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 |
|---|---|---|---|
| * | — | Total Shoulder System (Encore) 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 KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
This humeral stem will be used as part of a total shoulder system intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural humeral head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. The humeral stem may be used with or without bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.
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/K991603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991603: Grit Blasted Humeral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991603
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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