(88 days)
The KFx Peek Bone Anchor with Pre-Attached Sutures and Delivery Handle is intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.
Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions. Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.
Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
The KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle is intended for the fixation of soft tissue to bone using Teleflex ForceFiber™ #2 nonabsorbable braided suture. The KFx PEEK Bone Anchor with Pre-Attached Sutures consists of a fixation device pre-loaded with suture in a delivery (insertion) handle. The PEEK bone anchor can be used in open or arthroscopic procedures.
The provided text does not describe acceptance criteria for a device, nor does it detail a study proving the device meets said criteria.
Instead, the document is a 510(k) summary for the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle. This type of document is submitted to the FDA to demonstrate that a new device is "substantially equivalent" to an already legally marketed device (predicate device), meaning it is as safe and effective.
Here's why the requested information cannot be extracted from this text:
- Acceptance Criteria & Device Performance: The document states that "Non-clinical test data has established that the devices satisfies functional performance requirements and is safe and effective when used as indicated." However, it does not list specific acceptance criteria (e.g., tensile strength threshold, insertion force limits) or the reported performance values from those tests. It merely makes a general claim.
- Study Details (Sample Size, Ground Truth, Training Set, etc.): The document only mentions "Non-clinical test data." It does not provide any specifics about the studies conducted, such as sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for either test or training sets. This is typically because a 510(k) submission for a device like a bone anchor relies heavily on material equivalence, design similarity, and established performance of predicate devices, rather than clinical trials with human subjects or AI algorithm validation studies that would require such detailed information.
In summary, the provided text confirms the device's substantial equivalence to predicate devices based on materials, design, and operation, and mentions "non-clinical test data" confirming functional performance requirements. However, it does not offer the detailed breakdown of acceptance criteria and study particulars you've requested.
§ 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.