# K060172: Rema Shaver Blades

- Pathway: 510(k) (Traditional)
- Applicant: Rema Medizintechnik GmbH.
- Decided: May 31, 2006 after 128 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: 5 generations back to K862807 (1986). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023777: Arthronet Blackline 2 and 3 Piece Arthroscopic Blades, Models 123, 133, 153, 163, 173 and 183, Arthronet Medical, Inc. (2002) Summary page 1.
- K953695: Dyonics Disposable Arthroscopic Blades, Smith & Nephew Dyonics, Inc. (1995) Summary page 1.
- K955914: Limited Reuse Arthroscopic Blades, Smith & Nephew Dyonics, Inc. (1996) Summary page 1.
- K901735: Arthroscopic Surgery Blades DY-3440, 3443, 3444, Micro-Aire Surgical Instruments, Inc. (1990) Summary page 1.
- K963332: Thermo-Plastic Shaver Blades, Stryker Endoscopy (1996) Summary page 1.
- K943985: Limited Reuse Blades, Linvatec Corp. (1994) Summary page 1.
- K990524: E9000 System, Linvatec Corp. (1999) Summary page 1.
- K041824: X-Treme Arthroscopic Pump and Shaver System, Future Medical Systems, SA (2005) Summary page 1.
- K030009: Ksea Powershaver System S2, Karl Storz Endoscopy (2003) Summary page 1.

## Indications for use
The REMA Shaver Blades are intended to provide shaving, cutting and abrading of bone and tissue during arthroscopic surgical procedures conducted by qualified surgeons.

Source page: https://510kreport.com/device/K060172
Methodology: https://510kreport.com/methodology