510(k) · Cleared
ClearedStryker Total Performance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Cleared on Dec 15, 1994 after a 146-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 732 devices in its family, counting itself, has a Class I recall. 731 later devices descend from it.
- Decided
- Dec 15, 1994
- Review
- 146 days
- Class
- Class I
- Product code
- HWE
- Recalls
- None
- Predicates
- 0
731 later devices descend from it, 5 citing it directly. 1 of the 732 devices in this family, counting this one, has a Class I recall.
- This deviceK943589 Stryker Total Performance SystemStryker Corp. · 1994
- Descendant · cites it directly · 478 of its ownK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- Descendant · 2 generations on · 477 of its ownK990524 E9000 SystemLinvatec Corp. · 1999
- Descendant · cites it directly · 447 of its ownK012453 Sodem High Speed System (Electric) (General Orthopedics & Plastic…Sodemsystems · 2001
- Descendant · 3 generations on · 447 of its ownK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
- Descendant · 3 generations on · 446 of its ownK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
Showing 5 of 731 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 731 · See all- K981637Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998 · cites it directly478descendants
- K990524E9000 SystemLinvatec Corp. · 1999 · 2 generations on477descendants
- K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems · 2001 · cites it directly447descendants
- K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001 · 3 generations on447descendants
- K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001 · 3 generations on446descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943589 | Stryker Total Performance System | Stryker Corp. | 1994 | — |
| +1 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| +2 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| +1 | K012453 | Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) | Sodemsystems | 2001 | — |
| +3 | K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery) | Sodemsystems | 2001 | — |
| +3 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 13 | 0 |
| 2009 | 5 | 0 |
| 2010 | 12 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 14 | 0 |
| 2014 | 13 | 0 |
| 2015 | 20 | 0 |
| 2016 | 23 | 0 |
| 2017 | 24 | 0 |
| 2018 | 31 | 0 |
| 2019 | 34 | 0 |
| 2020 | 38 | 0 |
| 2021 | 58 | 1 |
| 2022 | 70 | 0 |
| 2023 | 79 | 0 |
| 2024 | 89 | 0 |
| 2025 | 99 | 0 |
| 2026 | 71 | 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.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (731)
See all 7315 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981637 | Integrated Drive/Pump System for Otolaryngology | 1998 | 478 |
| K012453 | Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) | 2001 | 447 |
| K991696 | Stryker Hermes-Ready Total Performance System | 1999 | 253 |
| K053526 | Microspeed Uni Motor System | 2006 | 12 |
| K143191 | IntelliSense Drill | 2015 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K981637 (Linvatec Corp., 1998) has gone furthest, with 478 descendants of its own.
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 | — |
https://510kreport.com/device/K943589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943589: Stryker Total Performance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943589
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026