510(k) · Cleared
ClearedTotal Performance System Shaver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · HRX Arthroscope
Cleared on Oct 24, 1997 as substantially equivalent to K953096 (Smith & Nephew Richards, Inc., 1995) after a 59-day review. Its family tree reaches back 1 generation to 1995. 11 later devices descend from it.
- Decided
- Oct 24, 1997
- Review
- 59 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953096 (1995). 11 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK953096 Essential Shaver SystemSmith & Nephew Richards, Inc. · 1995
- This deviceK973195 Total Performance System ShaverStryker Endoscopy · 1997
- Descendant · cites it directly · 4 of its ownK071859 Stryker Crossfire SystemStryker Endoscopy · 2007 · Recalled
- Descendant · 2 generations on · 2 of its ownK162770 Relign SystemRelign Corporation · 2017
- Descendant · cites it directly · 2 of its ownK061134 Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme · 2006
- Descendant · 3 generations on · 1 of its ownK233493 Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera…Relign Corporation · 2023
- Descendant · 2 generations on · 1 of its ownK092977 Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K071859Stryker Crossfire SystemStryker Endoscopy · 2007 · cites it directly4descendants
- K162770Relign SystemRelign Corporation · 2017 · 2 generations on2descendants
- K061134Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme · 2006 · cites it directly2descendants
- K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation · 2023 · 3 generations on1descendant
- K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme · 2010 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953096 | Essential Shaver System | Smith & Nephew Richards, Inc. | 1995 | — |
| 0 (this device) | K973195 | Total Performance System Shaver | Stryker Endoscopy | 1997 | — |
| +1 | K071859 | Stryker Crossfire System | Stryker Endoscopy | 2007 | 2 |
| +2 | K162770 | Relign System | Relign Corporation | 2017 | — |
| +1 | K061134 | Eberle Shaver System C2 and Shaver Blades | Efs Eberle Feinwerktechnische Systeme | 2006 | — |
| +3 | K233493 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver… | Relign Corporation | 2023 | — |
| +2 | K092977 | Eberle Shaver System Accessories | Efs Eberle Feinwerktechnische Systeme | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K953096 | Essential Shaver SystemSummary page 1…TY AND EFFECTIVENESS FOR TPS SHAVER HANDPIECE The Total Performance System Shaver Handpiece is substantially equivalent to the Smith & Nephew Dyonics EP-1 Shaver 510(k) 953096. The Total Performance System Shaver handpiece, constructed of a motor housing with a coupling mechanism for securing cutters an… | 1995 |
What descends from it? (11)
See all 115 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?
Total Performance System Shaver handpiece is intended to be used in conjunction with the Stryker Total Performance System by surgeons in the following orthopedic joints:
Knee
Shoulder
Ankle
Elbow
Wrist
Hip
Temporamandibular.
The Total Performance System Shaver Handpiece will be used to resect tissue and bur bone.
Examples of uses of the product would include resection of tomn knee cartilage, subacromial decompression and resection of synovial tissue in other joints.
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/K973195 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973195: Total Performance System Shaver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973195
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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