# K991696: Stryker Hermes-Ready Total Performance System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Oct 25, 1999 after 160 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931783 (1993). 11 ancestors in all.
253 later devices descend from it; 6 cite it directly.
0 of 265 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974771: Stryker SE5 Arthroscopy System with Hermes Voice Control, Stryker Endoscopy (1998) Summary page 1.
- K973700: Hermes Operating Room Control Center, Computer Motion, Inc. (1998) Summary page 1.
- K980787: Hermes Operating Room Control Center with the Wom 20L Insufflator, Computer Motion, Inc. (1998) Summary page 1.
- K942956: Surgical Instruments and Accessories, Stryker Corp. (1994) Summary page 1.
- K943540: Surgical Cutting Burs, Stryker Corp. (1994) Summary page 1.
- K943589: Stryker Total Performance System, Stryker Corp. (1994) Summary page 1.
- K943541: 75K Staight Drill, Stryker Corp. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K943563: Comfit Blue Powder Free Examination Gloves, Wembley Rubber Products (M) Sdn Bhd (1995). 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.
- K943552: Powder-Free Gloves, Healthcare Gloves Sdn Bhd (1994). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K032117: Stryker Total Performance (TPS) System (2003), 238 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K991696
Methodology: https://510kreport.com/methodology