# K220901: S-Core Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Subchondral Solutions, Inc.
- Decided: Jul 29, 2022 after 123 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962823 (1996). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143745: Arthrex Corkscrew and SwiveLock Suture Anchors, Arthrex, Inc. (2015) Summary page 5.
- K191995: S4 Screw System, Subchondral Solutions, Inc. (2020) Summary page 5.
- K162171: S4 Screw System™, Subchondral Solutions (2017) Summary page 5.

## Indications for use
The S-Core® Implant System (6.0 mm - 10.0 mm diameter) is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair. Hip: Capsular repair, acetabular labral repair, gluteus medius repair. The S-Core® Implant System consists of screws and accessories and is generally intended for fixation of fracture, fusion and osteotomies of large and small bones appropriate for the size of device. These large and small bones may include the following: Fixation of small bone fragments, such as apical fragments (patellar rim, navicular), minimally invasive reconstruction of fractures and joints, adjuvant for osteosynthesis in complex joint fractures, multifragment joint fractures, simple metaphyseal fractures, fractures of the wrist, ankle, elbow, and shoulder, condylar fractures, osteochrondritis dissecans, osteochondral fixation, fractures, and fragments (talar, vault, femoral condyle), intra-articular fractures, ligament avulsion injuries, ligament fixation, other small fragments, cancellous bone fragments (talus) or fractures, small joint fusion, areas where accurate screw placement is vital, metatarsal and phalangeal osteotomies, fractures of the tarsals, metatarsals and other fractures of the foot, avulsion fractures and fractures of metatarsal V, tarso-metatarsal and metatarso-phalangeal arthrodesis, fractures of small joints, such as: ankle fractures, navicular fractures, fractures of the fibula, malleolus, and calcaneus, distal tibia and pilon fractures, acetabular fractures, tarsal fusions, calcaneal and talar fractures, subtalar arthrodesis, ankle arthrodesis, other fractures of the pelvic ring, fractures of the femoral head and neck, supracondylar femoral fracture, slipped capital femoral epiphyses, an adjunct to DHIS in basilar neck fractures, intercondylar femur fractures, intracapsular fractures of the hip, fractures of the distal femur and proximal tibia, patellar fractures, tibial plateau fractures, small fragments of the hand and wrist, fractures of the carpals and metacarpals, carpal and metacarpal arthrodesis, scaphoid fracture and other fractures of the hand, phalangeal and interphalangeal fractures, fractures of the ulna and radius, radial head fractures, fractures of the olecranon and distal humerus, humeral head fractures, ligament fixation at the proximal humerus, glenoid fractures.

Source page: https://510kreport.com/device/K220901
Methodology: https://510kreport.com/methodology