# K971253: Various Arthroscopes, Endoscopic Blades, Manual Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 13, 1997 after 71 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: 2 generations back to K833587 (1983). 12 ancestors in all.
60 later devices descend from it; 5 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771218: Intra-Articular Shaver, Dyonics, Inc. (1978) Summary page 1.
- K820367: Intra-Articular Surgical System, Dyonics, Inc. (1982) Summary page 1.
- K880150: Pacesetter (TM) 3500 Arthroscopic Surgical System, Dyonics, Inc. (1988) Summary page 1.
- K914559: Small Joint System, Smith & Nephew Dyonics, Inc. (1992) Summary page 1.
- K961228: Karl Storz Magnifying Arthrosocpes, KARL STORZ Endoscopy-America, Inc. (1996) Summary page 1.
- K954989: Dyonics Disposable Endoscopic Surgery Blades, Smith & Nephew Dyonics, Inc. (1995) Summary page 1.
- K904284: Arthroscopic Surgical Blade, Smith & Nephew Dyonics, Inc. (1990) Summary page 1.
- K953695: Dyonics Disposable Arthroscopic Blades, Smith & Nephew Dyonics, Inc. (1995) Summary page 1.
- K934299: Dyonics Disposable Arthroscopic Surgery Blades Modification, Smith & Nephew Dyonics, Inc. (1994) Summary page 1.
- K912453: Intelijet TM Fluid Management System, Smith & Nephew Dyonics, Inc. (1991) Summary page 1.
- K833587: Disposable Arthroscopy Blade, Dyonics, Inc. (1983) Summary page 1.
- K900070: Modified Uses of the Arthroscopic Surgical System, Dyonics, Inc. (1990) Summary page 1.

## Cited in the summary but kept off the family tree
- K941038: Unnamed device. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K043395: Smith & Nephew Videoarthroscope (2005), 32 descendants of its own
- K072879: Innervue Diagnostic Scope System (2008), 30 descendants of its own
- K082293: Surgview Integrated Visualization System (2008), 21 descendants of its own
- K080560: Henke Sass Wolf of America Arthroscope (2008), 21 descendants of its own
- K093717: C-Mor Visualization Device (2010), 16 descendants of its own

## Indications for use
The Smith & Nephew, Inc., Endoscopy Division Arthroscopes and Accessories are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist and jaw, also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate. The Smith & Nephew, Inc., Endoscopy Division sterile, disposable Endoscopic Surgery Blades as indicated for use during arthroscopic resection of soft and osseous tissue in various large and small articular cavities including the hip joint. Blades which are size-appropriate are indicated for use in the following joints : shoulder, knee, elbow, ankle, wrist, jaw and the hip joint.

Source page: https://510kreport.com/device/K971253
Methodology: https://510kreport.com/methodology