510(k) · Cleared
ClearedThermo-Plastic Shaver Blades
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · HRX Arthroscope
Cleared on Oct 11, 1996 as substantially equivalent to K940515 (Linvatec Corp., 1994) after a 49-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Oct 11, 1996
- Review
- 49 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940515 (1994). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK940515 Poly BladesLinvatec Corp. · 1994
- This deviceK963332 Thermo-Plastic Shaver BladesStryker Endoscopy · 1996
- Descendant · cites it directly · 0 of its ownK060172 Rema Shaver BladesRema Medizintechnik GmbH. · 2006
- Descendant · cites it directly · 0 of its ownK012635 Reprocessed Stryker Arthroscopic ShaversAlliance Medical Corp. · 2001 · Recalled
- Descendant · cites it directly · 0 of its ownK012605 Reprocessed Athroscopics BursAlliance Medical Corp. · 2001 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940515 | Poly Blades | Linvatec Corp. | 1994 | — |
| 0 (this device) | K963332 | Thermo-Plastic Shaver Blades | Stryker Endoscopy | 1996 | — |
| +1 | K060172 | Rema Shaver Blades | Rema Medizintechnik GmbH. | 2006 | — |
| +1 | K012635 | Reprocessed Stryker Arthroscopic Shavers | Alliance Medical Corp. | 2001 | 8 |
| +1 | K012605 | Reprocessed Athroscopics Burs | Alliance Medical Corp. | 2001 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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 |
|---|---|---|---|
| * | K940515 | Poly BladesSummary page 1…VENESS FOR THERMO-PLASTIC SHAVER BLADES The Thermo-Plastic Shaver Blade is substantially equivalent to the Linvatec, Merlin Polyblade shaver manufactured by Linvatec per K940515. ) The Thermo-Plastic Shaver Blades, consisting of an inner Thermo-Plastic and stainless steel tube which rotates inside of a st… | 1994 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The disposable Thermo-Plastic Shaver Blades are for orthopedic use and will be provided sterile for single use applications.
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/K963332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963332: Thermo-Plastic Shaver Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963332
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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