510(k) · Cleared
ClearedS-Core Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Subchondral Solutions, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 29, 2022 as substantially equivalent to K143745 (Arthrex, Inc., 2015) and 2 other predicates after a 123-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Jul 29, 2022
- Review
- 123 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K962823 (1996). 102 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
- 2 generations backK162171 S4 Screw System™Subchondral Solutions · 2017
- 1 generation backK191995 S4 Screw SystemSubchondral Solutions, Inc. · 2020
- This deviceK220901 S-Core Implant SystemSubchondral Solutions, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 9 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 8 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 7 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 6 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 5 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 4 generations backK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
- 3 generations backK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
- 2 generations backK162171 S4 Screw System™Subchondral Solutions · 2017
- 1 generation backK191995 S4 Screw SystemSubchondral Solutions, Inc. · 2020
- This deviceK220901 S-Core Implant SystemSubchondral Solutions, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −9 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −8 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −7 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −6 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −5 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −4 | K120493 | Mini Cannulated Headed and Headless Screw Set | Instratek, Inc. | 2012 | 1 |
| −3 | K123890 | Acumed Cannulated Screw System | Acumed, LLC | 2013 | 2 |
| −2 | K162171 | S4 Screw System™ | Subchondral Solutions | 2017 | — |
| −1 | K191995 | S4 Screw System | Subchondral Solutions, Inc. | 2020 | — |
| 0 (this device) | K220901 | S-Core Implant System | Subchondral Solutions, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 12 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143745 | Arthrex Corkscrew and SwiveLock Suture AnchorsSummary page 5…h or threaded bone fixation fastener Device Class Class II Product Code: MBI, HWC Predicate Devices Primary Predicate: Arthrex Corkscrew Suture Anchor, K143745 Additional Predicates: Subchondral Solutions, Inc. S4 Screw System™, K191995 Subchondral Solutions, Inc. S… | 2015 |
| * | K191995 | S4 Screw SystemSummary page 5…e: MBI, HWC Predicate Devices Primary Predicate: Arthrex Corkscrew Suture Anchor, K143745 Additional Predicates: Subchondral Solutions, Inc. S4 Screw System™, K191995 Subchondral Solutions, Inc. S4 Screw System™, K162171 Device Description The S-Core® Implants are titaniu… | 2020 |
| * | K162171 | S4 Screw System™Summary page 5…Suture Anchor, K143745 Additional Predicates: Subchondral Solutions, Inc. S4 Screw System™, K191995 Subchondral Solutions, Inc. S4 Screw System™, K162171 Device Description The S-Core® Implants are titanium screws that are threaded, headless, cannulated devices offered in diameters… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 9 companies; a new generation was cleared every 2.6 years on median.
- 16 of the 102 ancestors have a recall of any class.
- 3 other devices also cite its predicate K143745.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
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…
Read the full statement (419 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220901: S-Core Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220901
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026