510(k) · Cleared
ClearedStryker Hermes-Ready Total Performance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · DZI Drill, Bone, Powered
Cleared on Oct 25, 1999 as substantially equivalent to K974771 (Stryker Endoscopy, 1998) and 6 other predicates after a 160-day review. Its family tree reaches back 4 generations to 1993. 253 later devices descend from it.
- Decided
- Oct 25, 1999
- Review
- 160 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 4 generations to K931783 (1993). 11 ancestors in all. 253 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 3 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 2 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 1 generation backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- This deviceK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- Descendant · cites it directly · 238 of its ownK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- Descendant · cites it directly · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 4 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Showing 5 of 253 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 253 · See all- K032117Stryker Total Performance (TPS) SystemStryker Instruments · 2003 · cites it directly238descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · cites it directly226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 4 generations on192descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −3 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −2 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −1 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| 0 (this device) | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| +1 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| +1 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +2 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +3 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +4 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 11 | 0 |
| 2009 | 3 | 0 |
| 2010 | 10 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 9 | 0 |
| 2014 | 9 | 0 |
| 2015 | 11 | 0 |
| 2016 | 11 | 0 |
| 2017 | 8 | 0 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 12 | 0 |
| 2022 | 24 | 0 |
| 2023 | 15 | 0 |
| 2024 | 28 | 0 |
| 2025 | 33 | 0 |
| 2026 | 15 | 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 DZI? 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 DZI device
- #1 K253776 Implantmed Plus II & Piezomed Plus II Modulescore 12.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974771 | Stryker SE5 Arthroscopy System with Hermes Voice ControlSummary page 1…assification Name: Surgical instrument motors and accessories/attachments 3) Substantially equivalent to Stryker SES Arthroscopy System with Hermes Voice Control 510(k) 974771, HERMES™ 510(k)’s K973700 and K980787, and Stryker Total Performance System K942956, K943540, K943589, K943563/52, K943541. 4) T… | 1998 |
| * | K973700 | Hermes Operating Room Control CenterSummary page 1…al instrument motors and accessories/attachments 3) Substantially equivalent to Stryker SES Arthroscopy System with Hermes Voice Control 510(k) 974771, HERMES™ 510(k)’s K973700 and K980787, and Stryker Total Performance System K942956, K943540, K943589, K943563/52, K943541. 4) The Stryker HERMES-Ready™ T… | 1998 |
| * | K980787 | Hermes Operating Room Control Center with the Wom 20L InsufflatorSummary page 1…t motors and accessories/attachments 3) Substantially equivalent to Stryker SES Arthroscopy System with Hermes Voice Control 510(k) 974771, HERMES™ 510(k)’s K973700 and K980787, and Stryker Total Performance System K942956, K943540, K943589, K943563/52, K943541. 4) The Stryker HERMES-Ready™ Total Perform… | 1998 |
| * | K942956 | Surgical Instruments and AccessoriesSummary page 1…antially equivalent to Stryker SES Arthroscopy System with Hermes Voice Control 510(k) 974771, HERMES™ 510(k)’s K973700 and K980787, and Stryker Total Performance System K942956, K943540, K943589, K943563/52, K943541. 4) The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting… | 1994 |
| * | K943540 | Surgical Cutting BursSummary page 1…equivalent to Stryker SES Arthroscopy System with Hermes Voice Control 510(k) 974771, HERMES™ 510(k)’s K973700 and K980787, and Stryker Total Performance System K942956, K943540, K943589, K943563/52, K943541. 4) The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drillin… | 1994 |
| * | K943589 | Stryker Total Performance SystemSummary page 1…t to Stryker SES Arthroscopy System with Hermes Voice Control 510(k) 974771, HERMES™ 510(k)’s K973700 and K980787, and Stryker Total Performance System K942956, K943540, K943589, K943563/52, K943541. 4) The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reamin… | 1994 |
| Kept off the family tree | K943563 | FDA’s K943563 is Comfit Blue Powder Free Examination Gloves Our OCR of the scanned summary read K943563, FDA’s number for Comfit Blue Powder Free Examination Gloves (Wembley Rubber Products (M) Sdn Bhd). Its FDA name has none of the distinctive words the summary uses for the device it names, “Stryker Total Performance System”. Kept off the family tree. Summary page 1…ker SES Arthroscopy System with Hermes Voice Control 510(k) 974771, HERMES™ 510(k)’s K973700 and K980787, and Stryker Total Performance System K942956, K943540, K943589, K943563/52, K943541. 4) The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decort… | 1995 |
| Kept off the family tree | K943552 | FDA’s K943552 is Powder-Free Gloves Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1994 |
| * | K943541 | 75K Staight DrillSummary page 1…roscopy System with Hermes Voice Control 510(k) 974771, HERMES™ 510(k)’s K973700 and K980787, and Stryker Total Performance System K942956, K943540, K943589, K943563/52, K943541. 4) The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and… | 1995 |
What descends from it? (253)
See all 2536 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032117 | Stryker Total Performance (TPS) System | 2003 | 238 |
| K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | 2004 | 226 |
| K032303 | Stryker Consolidated Operating Room Equipment (Core) System | 2004 | 14 |
| K040369 | Stryker Consolidated Operating Room Equipment (Core) System | 2004 | 7 |
| K040300 | Stryker Consolidated Operating Room Equipment (Core) | 2004 | 7 |
| K014060 | Microaire 1000E System | 2002 | 7 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K032117 (Stryker Instruments, 2003) has gone furthest, with 238 descendants of its own.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZI
300in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZI
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZI
39in 2025
MAUDE reports naming product code DZI, 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 | 2 | — | 0 | 53 |
| 2008 | 4 | 171 | 0 | 45 |
| 2009 | 5 | 220 | 1 | 22 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 4 | 191 | 0 | 25 |
| 2013 | 0 | — | 0 | 57 |
| 2014 | 1 | — | 0 | 50 |
| 2015 | 3 | 123 | 0 | 39 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 3 | 290 | 0 | 73 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 3 | 300 | 0 | 55 |
| 2021 | 0 | — | 0 | 84 |
| 2022 | 0 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 63 |
| 2024 | 2 | — | 0 | 58 |
| 2025 | 1 | — | 0 | 39 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Stryker HERMES-Ready™ Total Performance System is 4ntended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often in orthopedics, dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal. The…
Read the full statement (130 words)
The Stryker HERMES-Ready™ Total Performance System is 4ntended for use in the cutting, drilling,
reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical
procedures. Procedures for use on bone are often in orthopedics, dental, oral surgery, maxilliofacial,
plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation
devices. It can also be used to cut metal.
The endoscopic applications with TPS include use of the SES Small Joint Shaver in the wrist are any need
for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage
flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of
osseous lesions such as eburnated articular surfaces or osteophytes.
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/K991696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991696: Stryker Hermes-Ready 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/K991696
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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