510(k) · Cleared
ClearedPowercut Gold Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Cleared on Aug 5, 1996 as substantially equivalent to K863696 (American Edwards Laboratories, 1986) after a 74-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Aug 5, 1996
- Review
- 74 days
- Class
- Class I
- Product code
- HWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863696 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK863696 Arthroscopic Surgical Power DeviceAmerican Edwards Laboratories · 1986
- This deviceK962022 Powercut Gold Surgical SystemBaxter Healthcare Corp · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863696 | Arthroscopic Surgical Power Device | American Edwards Laboratories | 1986 | — |
| 0 (this device) | K962022 | Powercut Gold Surgical System | Baxter Healthcare Corp | 1996 | — |
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 HWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K863696 | Arthroscopic Surgical Power DeviceSummary page 1…Road MPK McGaw Park, IL (847) 785-3322 May 1996 Modified PowerCut® Gold Surgical System Class | per 21CFR § 878.4820 PowerCut® Gold Battery Powered Surgical System (K863696) The modified PowerCut® Gold Surgical system will be a reusable, non-sterile, AC powered device. It is designed for use in arthr… | 1986 |
| * | — | Dyonics PS3500 Named without a submission number | |
| * | — | Stryker SE3 Named without a submission number | |
| * | — | Linvatec Concepts IntraArc® 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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All HWE devicesHWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HWE
Too few HWE 510(k)s in any year since 2007 to give a median.
Recalls per year · HWE
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWE
2,848in 2025
MAUDE reports naming product code HWE, 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 | 123 |
| 2008 | 0 | — | 0 | 72 |
| 2009 | 0 | — | 4 | 180 |
| 2010 | 0 | — | 2 | 297 |
| 2011 | 1 | — | 2 | 138 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 1,243 |
| 2014 | 0 | — | 3 | 3,794 |
| 2015 | 1 | — | 5 | 5,567 |
| 2016 | 0 | — | 2 | 4,974 |
| 2017 | 0 | — | 1 | 5,074 |
| 2018 | 0 | — | 0 | 3,589 |
| 2019 | 0 | — | 0 | 3,452 |
| 2020 | 0 | — | 0 | 3,248 |
| 2021 | 0 | — | 0 | 3,140 |
| 2022 | 0 | — | 0 | 3,327 |
| 2023 | 0 | — | 0 | 3,397 |
| 2024 | 0 | — | 0 | 3,686 |
| 2025 | 0 | — | 0 | 2,848 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Modified PowerCut® Gold Surgical System is designed for use in arthroscopic surgical procedures where intra-articular tissue resection, shaving, and/or abrading the knee or shoulder joint is required. The system is used in conjunction with direct arthroscopic camera visualization utilizing a separate port of entry (incision site).
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/K962022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962022: Powercut Gold Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962022
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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