# K973195: Total Performance System Shaver

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Oct 24, 1997 after 59 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953096 (1995). 1 ancestor in all.
11 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953096: Essential Shaver System, Smith & Nephew Richards, Inc. (1995) Summary page 1.

## Most influential descendants
- K071859: Stryker Crossfire System (2007), 4 descendants of its own
- K162770: Relign System (2017), 2 descendants of its own
- K061134: Eberle Shaver System C2 and Shaver Blades (2006), 2 descendants of its own
- K233493: Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) (2023), 1 descendant of its own
- K092977: Eberle Shaver System Accessories (2010), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K973195
Methodology: https://510kreport.com/methodology