SUBCHONDRAL SOLUTIONS

FDA Device Registration & Listing · Costa Mesa, CA, US · Registration 3016660811

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016660811
FEI Number
3016660811
Entity Name
SUBCHONDRAL SOLUTIONS
City/State/Country
Costa Mesa, CA, US
Establishment Address
1725 Monrovia Ave, Suite C-5, Costa Mesa, CA 92627, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Subchondral Solutions (Owner Number: 10062793)
Owner / Operator Contact Address
1725 Monrovia Ave, Costa Mesa, CA 92627, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SCS UE Implant and Delivery System S-Core HA Coated Implant S-Core HA Coated Implant SCS UE Implant and Delivery System SS Sports Implant and Delivery System S-Core Delivery Instruments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-04-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-03-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-05-19
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-02-21

Official Correspondent

James Barley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Subchondral Solutions
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K193295 Parcus Medical, LLC Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor 2020-01-23
K193606 Conmed Corporation Y-Knot OneStep Anchor 2020-01-22
K984200 R. Thomas Grotz, M.D., Inc. STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE 1999-01-21
K171060 Riverpoint Medical OrthoButton AL 2017-06-02
K231867 Paragon 28, Inc. Grappler Suture Anchor System 2023-08-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

Similar Registrations

Registration Number Establishment Name Location
1219930 Covidien North Haven, CT, US
1054811 Sterigenics U.S. LLC MULBERRY, FL, US
3016851379 Arthrex Distribution Hub EMEA B.V. Venlo Limburg, NL
3011989923 DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Istanbul, TR
3012818475 Device Innovation Company Limited Bangkok Krung Thep Maha Nakhon, TH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016660811. Last updated year: 2026. Please use registration number 3016660811 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.