# K101484: Compressyn Band

- Pathway: 510(k) (Traditional)
- Applicant: Dallen Medical
- Decided: Apr 1, 2011 after 308 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K761228 (1976). 84 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile, KLS Martin L.P. (2007) Summary page 1.
- K930015: Sternal Band, Stony Brook Surgical Innovations, Inc. (1993) Summary page 1.
- K993286: Pioneer Silicoat Sternal Cable, Pioneer Surgical Technology (1999) Summary page 1.
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 1.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 1.
- K990088: Synthofil Nonabsorbable Pet Surgical Suture, Aesculap, Inc. (1999) Summary page 1.
- (no number) Mersilene Polyester Fiber Suture: named in the summary without a submission number

## Most influential descendants
- K130431: Compressyn Band (2013), 4 descendants of its own
- K133858: Tensyn Band (2014), 3 descendants of its own
- K141264: Tensyn Band, Tensyn Fracture Plates (2014), 2 descendants of its own
- K143092: Tensyn Plug (2015), 1 descendant of its own
- K150359: Tensyn Plug (2015), 0 descendants of its own

## Indications for use
The Compressyn Tm Band is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

Source page: https://510kreport.com/device/K101484
Methodology: https://510kreport.com/methodology