510(k) · Cleared
ClearedPoly Blades
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · HRX Arthroscope
Cleared on May 26, 1994 after a 111-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 26, 1994
- Review
- 111 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK940515 Poly BladesLinvatec Corp. · 1994
- Descendant · cites it directly · 3 of its ownK963332 Thermo-Plastic Shaver BladesStryker Endoscopy · 1996
- Descendant · 2 generations on · 0 of its ownK060172 Rema Shaver BladesRema Medizintechnik GmbH. · 2006
- Descendant · cites it directly · 0 of its ownK012630 Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK012613 Reprocssed Linvatec ShaversAlliance Medical, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 0 of its ownK012635 Reprocessed Stryker Arthroscopic ShaversAlliance Medical Corp. · 2001 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K963332Thermo-Plastic Shaver BladesStryker Endoscopy · 1996 · cites it directly3descendants
- K060172Rema Shaver BladesRema Medizintechnik GmbH. · 2006 · 2 generations on0descendants
- K012630Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc. · 2001 · cites it directly0descendants
- K012613Reprocssed Linvatec ShaversAlliance Medical, Inc. · 2001 · cites it directly0descendants
- K012635Reprocessed Stryker Arthroscopic ShaversAlliance Medical Corp. · 2001 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940515 | Poly Blades | Linvatec Corp. | 1994 | — |
| +1 | K963332 | Thermo-Plastic Shaver Blades | Stryker Endoscopy | 1996 | — |
| +2 | K060172 | Rema Shaver Blades | Rema Medizintechnik GmbH. | 2006 | — |
| +1 | K012630 | Reprocessed Linvatec Arthroscopic Burs | Alliance Medical, Inc. | 2001 | — |
| +1 | K012613 | Reprocssed Linvatec Shavers | Alliance Medical, Inc. | 2001 | 1 |
| +2 | K012635 | Reprocessed Stryker Arthroscopic Shavers | Alliance Medical Corp. | 2001 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 4 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
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?
- Of its descendants, K963332 (Stryker Endoscopy, 1996) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K940515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940515: Poly Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940515
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026