(26 days)
The CITRELOCK® DUO is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:
Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tendon Reattachment, Acromion-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.
The CITRELOCK® DUO is a two-piece design consisting of a cannulated, self-locking, CITRELOCK® implant made from CITREGEN® biomaterial coupled with an eyelet component made from PEEK. The CITRELOCK® DUO system consists of fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm.
The purpose of this Special 510(k) Device Modification is to advise the FDA of this line extension wherein an eyelet to accommodate suture was added to the previously 510(k) cleared CITRELOCK® "twist-ribbed", cannulated, self-locking bone anchor. The CITRELOCK® DUO device utilizes the same correspondingly sized and designed primary predicate, the CITRELOCK®, with the added PEEK eyelet at the tip of the device. These two components are sterile packaged together and mounted on a Cartridge that facilitates loading onto the Inserter instrument.
The CITRELOCK® DUO is made from CITREGEN® biomaterial, which is a resorbable, homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxyapatite (HA) and 40 wt.-% polyester. CITREGEN's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.
The eyelet is made from polyether ether ketone (PEEK) conforming to ASTM F2026. Suture material is not provided with the device.
This is a 510(k) summary for a medical device modification, not a study evaluating AI performance. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance with respect to AI (e.g., human reader improvement with AI assistance, standalone algorithm performance, training set details) is not applicable or cannot be extracted from this document.
However, I can provide information based on the performance data presented for this specific medical device modification:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit from FDA Guidance & Equivalence Claim) | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Maintain similar fixation strength to predicate devices. | "The results of these tests showed the worst case subject devices (e.g. smallest diameter, shortest length) to possess similar pull out strengths relative to the primary predicate devices (K200725, K22083) thereby confirming no measurable effect of the PEEK eyelet and presence of suture at the tip and adjacent to the device." |
| Sterility of implants, packaging, and shipping/handling maintained. | "V&V activities included adoption of previously performed validations for sterility of implants, packaging, and shipping and handling." |
| Meet packaging and shelf life requirements. | "Packaging and shelf life tests using real and accelerated time aging were performed with passing results. The labeled shelf-life of the product is three years based on the original test plans cleared in K200725 and K203334." |
| Meet bacterial endotoxin limits. | "Bacterial endotoxin testing (BET) showed CITREGEN® based test articles to meet endotoxin limits ( |
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.