510(k) · Cleared
ClearedAlexis Orthopaedic Wound Retractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · KGW Ring (Wound Protector), Drape Retention, Internal
Cleared on Apr 2, 2010 as substantially equivalent to K062907 (Applied Medical Resources, 2007) after a 77-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Apr 2, 2010
- Review
- 77 days
- Class
- Class II
- Product code
- KGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062907 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK062907 Alexis Wound RetractorApplied Medical Resources · 2007
- This deviceK100120 Alexis Orthopaedic Wound RetractorApplied Medical Resources Corp. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062907 | Alexis Wound Retractor | Applied Medical Resources | 2007 | — |
| 0 (this device) | K100120 | Alexis Orthopaedic Wound Retractor | Applied Medical Resources Corp. | 2010 | — |
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 KGW? 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 KGW device
- #1 K253531 Alexis® Lighted Wound Protector-Retractor…score 13.9 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K062907 | Alexis Wound RetractorSummary page 2…this type. For that reason, APPLIED created test protocols specifically designed to confirm safety and efficacy of the subject device relative to the predicate device of K062907. These tests include the device's: * 2&bility to refract a wouxid a Resistance to tearing during instrument exchanges… | 2007 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All KGW devicesKGW Ring (Wound Protector), Drape Retention, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KGW
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGW
Too few KGW 510(k)s in any year since 2007 to give a median.
Recalls per year · KGW
No recall names KGW since 2007.
Adverse event reports per year · KGW
15in 2025
MAUDE reports naming product code KGW, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 58 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Alexis Orthopaedic Wound Retractor is indicated for use to access the musculoskeletal system through an atraumatically retracted wound
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100120: Alexis Orthopaedic Wound Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100120
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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