Mitek PDS/PGA Staple
510(k) K021953
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021953 | Date20 Dec 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JDR
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mitek PDS/PGA Staple is a sterile, single-use absorbable fixation device classified as a Staple, Fixation, Bone under FDA classification JDR. It consists of a U-shaped polydioxanone (PDS) strap insert-molded around two polyglycolic acid (PGA) cones, designed to secure cartilage repair scaffolds such as autografts or membranes to articular cartilage lesions. The device leverages two well-characterized, absorbable polymers—PDS and PGA—to provide temporary fixation during tissue integration. Its absorbable nature eliminates the need for removal, ensuring biocompatibility and gradual resorption over time.
Implanted by orthopedic surgeons during knee cartilage repair procedures, the Mitek PDS/PGA Staple is intended for use in controlled surgical settings. Supplied sterile and intended for single-use, it adheres to FDA 510(k) clearance (K021953) under the Orthopedic (OR) advisory committee. The device requires no special storage conditions beyond standard sterile surgical supplies and is not MRI-compatible. Its absorbable design aligns with regulatory standards for temporary fixation implants, ensuring compliance with FDA classification and submission requirements.
Other devices from Mitek Worldwide
Questions
AI-generated answers, 1 Oct 2026
What is the Mitek PDS/PGA Staple used for?
The Mitek PDS/PGA Staple is designed to secure cartilage repair scaffolds, such as autografts or membranes, to articular cartilage lesions during knee surgery. Its U-shaped polydioxanone (PDS) strap, molded around polyglycolic acid (PGA) cones, provides temporary fixation to stabilize the graft while it integrates with surrounding tissue. The absorbable nature of the device ensures it gradually resorbs over time, eliminating the need for surgical removal.
How is the Mitek PDS/PGA Staple supplied and stored?
The device is supplied sterile and intended for single-use only. No special storage conditions are required beyond standard sterile surgical supply protocols. It should be stored in its original packaging until ready for use, ensuring it remains uncontaminated and ready for implantation.
Is the Mitek PDS/PGA Staple reusable or MRI-compatible?
The Mitek PDS/PGA Staple is explicitly designed for single-use only. Additionally, it is not MRI-compatible, meaning it should not be used in patients who require magnetic resonance imaging (MRI) scans post-implantation. Clinicians should verify MRI safety with the manufacturer if imaging is anticipated.
What materials are used in the Mitek PDS/PGA Staple, and why?
The device combines two absorbable polymers: polydioxanone (PDS) for the strap and polyglycolic acid (PGA) for the cones. PDS provides flexibility and strength, while PGA offers controlled degradation to support tissue integration. Both materials are biocompatible and designed to resorb gradually, ensuring the staple dissolves as the cartilage repair heals.
What regulatory clearance does the Mitek PDS/PGA Staple hold?
The Mitek PDS/PGA Staple holds FDA 510(k) clearance under the product code JDR (Staple, Fixation, Bone) and was reviewed by the Orthopedic (OR) advisory committee. The clearance (K021953) confirms it is substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness in its intended use.