(267 days)
No
The summary describes a mechanical screw system and its performance testing, with no mention of AI or ML capabilities.
Yes.
The device is described as "minimally invasive reconstruction of fractures and joints" and is indicated for various types of fractures and fusions, which are therapeutic interventions.
No
The device description clearly states it is a "collection of cannulated, headless screws," and the intended use describes its application in "minimally invasive reconstruction of fractures and joints" and as an "adjuvant for osteosynthesis," indicating a therapeutic/surgical purpose, not a diagnostic one.
No
The device description explicitly states "The S4 Screw System is collection of cannulated, headless screws having fenestrations on the head and within the thread pitch," indicating it is a physical hardware device (screws).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The S4 Screw System is described as a collection of cannulated, headless screws. These are physical implants used in surgical procedures.
- Intended Use: The intended use clearly describes the use of the screws for the reconstruction and fixation of fractures and joints within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
The device is a surgical implant used for orthopedic procedures, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Minimally invasive reconstruction of fractures and joints; Adjuvant for osteosynthesis in complex joint fractures; Multifragment joint fractures; Simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder, Condylar fractures; Osteochrondriis dissecans, Ostero-Chondral Fractures, Ligament avulsion injuries, Ligament fixation, Other small fragment, cancellous bone fractures, Small joint fusion. Areas where accurate sorew 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-metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures, Subtalar arthrodesis. Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Fractures of the fibula, malleolus, and calcaneus, Distal tibia and pilon fractures, Acetabular fractures of the pelvic ring; Fractures of the femoral head and neck, Supracondylar femoral fractures, Slipped capital femoral epiphyses, An adjunct to DHIS in basilar neck fractures, Intractures, Intracapsular fractures of the hip, Fractures of the distal femur and proximal tibia, Patellar fractures. Small fragments of the hand and wrist, Fractures of the carpals and metacarpals, Carnal and metacarpal arthrodesis. Scaphoid fracture and other fractures of the hand, Phalangeal and interphalangeal fractures of the ulna and radius. Radial head fractures. Fractures of the olecranon and distal humeral head fractures, Ligament fixation at the proximal humerus, Glenoid fractures.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The S4 Screw System is collection of cannulated, headless screws having fenestrations on the head and within the thread pitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, ankle, elbow, shoulder, Metatarsal, phalangeal, tarsals, metatarsals, foot, calcaneal, talar, fibula, malleolus, distal tibia, acetabular, pelvic ring, femoral head, femoral neck, distal femur, proximal tibia, patellar, hand, carpals, metacarpals, scaphoid, ulna, radius, radial head, olecranon, distal humerus, humeral head, proximal humerus, glenoid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of the S4 Screw System was performed, per ASTM F543. The selected tests include Torsional Properties, Insertion and Removal Torque, and Pullout Strength. In addition, information about the hydroxyapatite-coating is referenced in the Master File.
A packaging performance study was completed to validate packaging performance. Also, a sterilization validation study was also completed.
A Failure Modes and Effects Analysis (FMEA) was used to assess changes made to the subject S4 Screw System compared to the predicate S4 Screw System with regard to the modified intended use, as well as the additional sizes and HA coating. The analysis determined that the modifications resulted in an acceptable low risk category.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
April 18, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo, which includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
Subchondral Solutions, Inc. Michael Kolber Consultant 147 Hillbrook Drive Los Gatos, California 95032
Re: K191995
Trade/Device Name: S4 Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: July 19, 2019 Received: July 26, 2019
Dear Michael Kolber:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191995
Device Name S4 Screw SystemTM
Indications for Use (Describe)
Minimally invasive reconstruction of fractures and joints; Adjuvant for osteosynthesis in complex joint fractures; Multifragment joint fractures; Simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder, Condylar fractures; Osteochrondriis dissecans, Ostero-Chondral Fractures, Ligament avulsion injuries, Ligament fixation, Other small fragment, cancellous bone fractures, Small joint fusion. Areas where accurate sorew 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-metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures, Subtalar arthrodesis. Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Fractures of the fibula, malleolus, and calcaneus, Distal tibia and pilon fractures, Acetabular fractures of the pelvic ring; Fractures of the femoral head and neck, Supracondylar femoral fractures, Slipped capital femoral epiphyses, An adjunct to DHIS in basilar neck fractures, Intractures, Intracapsular fractures of the hip, Fractures of the distal femur and proximal tibia, Patellar fractures. Small fragments of the hand and wrist, Fractures of the carpals and metacarpals, Carnal and metacarpal arthrodesis. Scaphoid fracture and other fractures of the hand, Phalangeal and interphalangeal fractures of the ulna and radius. Radial head fractures. Fractures of the olecranon and distal humeral head fractures, Ligament fixation at the proximal humerus, Glenoid fractures.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
510(k) Number K191995
Submitter Name and Address
| Name: | Subchondral Solutions, Inc. |
|---|---|
| Contact: | Michael Kolber |
| Consultant, Regulatory Affairs | |
| Address: | 147 Hillbrook Drive |
| Los Gatos, CA 95032 | |
| Telephone: | 408-505-6626 |
| Date Prepared: | April 16, 2020 |
General Device Information
| Product Name: | S4 Screw System™ |
|---|---|
| Common Name: | Bone Screw System |
| Classification: | 21CFR888.3040, Smooth or threaded bone fixation fastener |
| Device Class: | Class II |
| Product Code: | HWC |
Predicate Devices
| Primary Predicate: | Subchondral Solutions, Inc. S4 Screw System (K162171) |
|---|---|
| Additional Predicates: | Acumed Cannulated Screw System (K123890) |
| Medacta International M.U.S.T. Sacral Iliac Screw and Pelvic Trauma | |
| System (K171595) | |
| Reference Devices: | Newclip Technics (K160617) |
| Tyber Medical, Trauma Screw (K153575) |
Device Description
The S4 Screw System is collection of cannulated, headless screws having fenestrations on the head and within the thread pitch.
Intended Use (Indications)
The S4 Screw System consists of screws and accessories and is generally intended for fixation of fracture, fusion and osteotomies of large and small bones appropriate for size of device. These large and small bones may include the following:
Minimally invasive reconstruction of fractures and joints; Adjuvant for osteosynthesis in complex joint fractures: Multifragment joint fractures; Simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder, Condylar fractures; Osteochrondritis dissecans, Ostero-Chondral Fractures, Ligament avulsion injuries, Ligament fixation, Other small fragment, cancellous bone 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
4
phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures, Subtalar arthrodesis, Ankle arthrodesis. Fractures of small joints, such as: Ankle fractures, Navicular fractures of the fibula, malleolus, and calcaneus, Distal tibia and pilon fractures, Acetabular fractures. Other fractures of the pelvic ring; Fractures of the femoral head and neck, Supracondylar femoral fractures, 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, Carnal and metacarpal arthrodesis, Scaphoid fracture and other fractures of the hand, Phalangeal and interphalangeal 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.
Comparison of Technology
The S4 Screw System (subject device) has a modified intended use compared to the predicate device, but identical to the Acumed Cannulated Screw System.
Also, additional sizes have been added (reference devices Newclip Technics, K160617 and Tyler Medical, K153575), as well as the optional addition of hydroxyapatite (HA) coating (additional predicate device Medacta Intl., K171595). The purpose of the additional sizes is to enable to repair larger bones, as appropriate for the size of the device. The purpose of the HA coating is to improve bone growth.
Summary of Non-Clinical Performance Testing Bench Test
Mechanical testing of the S4 Screw System was performed, per ASTM F543. The selected tests include Torsional Properties, Insertion and Removal Torque, and Pullout Strength. In addition, information about the hydroxyapatite-coating is referenced in the Master File.
Packaging and Sterilization
A packaging performance study was completed to validate packaging performance. Also, a sterilization validation study was also completed.
Risk Assessment/Analysis
A Failure Modes and Effects Analysis (FMEA) was used to assess changes made to the subject S4 Screw System compared to the predicate S4 Screw System with regard to the modified intended use, as well as the additional sizes and HA coating. The analysis determined that the modifications resulted in an acceptable low risk category.
Referenced Standards
| ASTM F136-13 - | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI
(Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS
R56401) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F899-12b - | Standard Specification for Stainless Steel for Surgical Instruments. |
| ASTM F1185-03 - | Standard Specification for Composition of Hydroxyapatite for Surgical
Implants |
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- Standard Specification and Test Methods for Metallic Medical Bone ASTM F543-17 -Screws
- ISO 11137-1:2017 Sterilization of health care products Radiation Part 1: Requirement for device validation and routine control of a sterilization process for medical devices
Statement of Equivalence
Based on similarities in indications for use and technological characteristics, as well as nonclinical performance testing, we believe the S4 Screw System is substantially equivalent to the predicate devices.