Parcus Twist AP Suture Anchors
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183501 FDA 510(k)
- FDA Product Code
- MAI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Parcus Twist AP Suture Anchors are biodegradable soft tissue fixation devices designed for attaching soft tissue to bone. Classified as a Class II medical device under FDA regulations, they are intended for orthopedic applications requiring secure, temporary fixation during surgical procedures.
These anchors are supplied sterile and intended for single-use in orthopedic surgeries, including rotator cuff repair, acromioclavicular separation repair, and other soft tissue-to-bone attachments. They are regulated under FDA 510(k) clearance (K183501) and comply with the requirements of 21 CFR 888.3030. No MRI safety information or reusable variants are specified in the data.
Frequently asked questions
Are the Parcus Twist AP Suture Anchors reusable or designed for single-use only?
The Parcus Twist AP Suture Anchors are explicitly intended for single-use only in orthopedic surgeries. This is clearly stated in the device description, which specifies they are supplied sterile and meant for one-time application during procedures like rotator cuff repair or acromioclavicular separation repair.
What types of orthopedic procedures are these anchors approved for?
While the device is classified for orthopedic applications, the exact approved procedures are not listed in the data. However, the description mentions they are designed for soft tissue-to-bone attachments, commonly used in surgeries like rotator cuff repair and acromioclavicular separation repair. Always verify intended use with the manufacturer or regulatory documentation for your specific case.
How are the Parcus Twist AP Suture Anchors supplied, and what should I check before use?
The anchors are supplied sterile, as noted in the device description. Before use, ensure the packaging remains intact and unopened to confirm sterility. Since they are biodegradable and single-use, they should not be reused or reprocessed. Always follow the manufacturer’s instructions for handling and storage to maintain sterility.
What regulatory pathway was followed for FDA clearance of these anchors?
The Parcus Twist AP Suture Anchors received FDA 510(k) clearance under the traditional review pathway, with the clearance number K183501. The decision was classified as *Substantially Equivalent (SESE)* and falls under the Orthopedic advisory committee (OR). The device complies with 21 CFR 888.3030, which governs biodegradable soft tissue fixation devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K183501 FDA 510(k) - Parcus Twist AP Suture Anchors, Parcus Twist AP Suture Anchors - healthcareequipment.org, Parcus Twist AP Suture Anchors (K183501) — FDA 510 (k) | Innolitics, PDF Suture Anchor Pamphlet - parcus.swdlab.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183501 | Class II | Active |
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Manufacturer
- Manufacturer
- Parcus Medical Llc
- FDA Applicant
- Parcus Medical, LLC
Sources (1)
- FDA 510(k) K183501 24 fields · synced Sep 20, 2026