# K021953: Mitek PDS/Pga Staple

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Worldwide
- Decided: Dec 20, 2002 after 190 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K946271 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946271: Vicryo* (Polyglactin 910) Braided Coated and Uncoated Synthetic Absorbable Suture, Dyed & Undyed, Braided and Monofilamt, ETHICON, Inc. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- P18331: PDS II Suture. Number could not be read Summary page 1.
- K970110: Bard Flexible Endoscopy Injection System (651019), Bard Medical Div. (1997). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K073281: Cais Staple (2008), 0 descendants of its own

## Indications for use
The Mitek PDS/PGA Staple is an absorbable implant used in the fixation of scaffolding (for example periosteal autograft, collagen membranes or synthetic scaffolding) to articular cartilage lesions of the knee.

Source page: https://510kreport.com/device/K021953
Methodology: https://510kreport.com/methodology