S4 Screw System™

K162171 · Subchondral Solutions · HWC · Sep 7, 2017 · Orthopedic

Device Facts

• Record ID: K162171
• Device Name: S4 Screw System™
• Applicant: Subchondral Solutions
• Product Code: HWC · Orthopedic
• Decision Date: Sep 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The S4 Screw System™ is indicated for fixation of small bone fragments, osteochondral fragments and cancellous fragments, appropriate for the device which may include the following: simple metaphyseal fractures; condylar fractures; osteochondritis dissecans; areas where accurate screw placement is vital; apical fragments (patellar); cancellous fragments (talus); osteochondral fragments (talar vault, femoral condyle); intra-articular fractures and osteochondral fixation and fractures.

Device Story

S4 Screw System™ consists of cannulated, headless metallic bone screws featuring fenestrations on the head and within the thread pitch. Used by orthopedic surgeons in clinical settings for internal fixation of small bone, osteochondral, and cancellous fragments. Device provides mechanical stabilization of fracture sites to facilitate healing. Operation involves surgical implantation to secure bone fragments. Benefits include accurate fixation in critical areas and stabilization of intra-articular fractures.

Clinical Evidence

Bench testing only. Mechanical testing (torsion, insertion, pushout) performed on worst-case components per ASTM F543 demonstrated performance equivalent to predicate devices. Bacterial endotoxin testing confirmed implants meet specified pyrogenicity limits.

Technological Characteristics

Cannulated, headless bone screws. Material: Titanium alloy (Ti-6Al-4V per ASTM F136). Features fenestrations on head and within thread pitch. Mechanical performance validated per ASTM F543.

Indications for Use

Indicated for fixation of small bone fragments, osteochondral fragments, and cancellous fragments in patients with simple metaphyseal fractures, condylar fractures, osteochondritis dissecans, intra-articular fractures, or specific apical/cancellous fragment injuries (e.g., patellar, talus, talar vault, femoral condyle).

Regulatory Classification

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.

Predicate Devices

• Acumed Cannulated Screw System (K123890)
• Arthrex Compression FT Screws (K132217)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three heads, representing the department's focus on health and human well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 7, 2017

Subchondral Solutions % Karen E. Warden, Ph.D. President Backroads Consulting Inc. PO Box 566 Chesterland, Ohio 44026

Re: K162171

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: August 7, 2017 Received: August 8, 2017

Dear Dr. Warden:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K162171

Device Name S4 Screw System™

#### Indications for Use (Describe)

The S4 Screw System™ is indicated for fixation of small bone fragments, osteochondral fragments and cancellous fragments, appropriate for the device which may include the following: simple metaphyseal fractures; condylar fractures; osteochondritis dissecans; areas where accurate screw placement is vital; apical fragments (patellar); cancellous fragments (talus); osteochondral fragments (talar vault, femoral condyle); intra-articular fractures and osteochondral fixation and fractures.

Type of Use (Select one or both, as applicable)

∑ Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510(k) Summary

| Date: | 7 August 2017 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Subchondral Solutions, Inc.<br>147 Hillbrook Drive<br>Los Gatos, CA 95032<br>Office: 408.891.9604 |
| Contact Person: | Sheryl McCoy, Chief Financial Officer and VP of Administration |
| 510(k) Contact: | Karen E. Warden, PhD<br>BackRoads Consulting Inc.<br>PO Box 566<br>Chesterland, OH 44026<br>Office: 440.729.8457 |
| Proposed Trade Name: | S4 Screw System™ |
| Common Name: | Bone screw |
| Device Classification: | Class II |
| Regulation Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation: | 888.3040 |
| Device Product Codes: | HWC |
| Device Description: | The S4 Screw System™ is collection of cannulated, headless screws<br>having fenestrations on the head and within the thread pitch. |
| Indications for Use: | The S4 Screw System™ is indicated for fixation of small bone fragments,<br>such as apical fragments, osteochondral fragments and cancellous<br>fragments, appropriate for the size of the device which may include the<br>following: simple metaphyseal fractures; condylar fractures; osteochondritis<br>dissecans; areas where accurate screw placement is vital; apical fragments<br>(patellar rim, navicular); cancellous fragments (talus); osteochondral<br>fragments (talar vault, femoral condyle); intra-articular fractures and<br>osteochondral fixation and fractures. |
| Materials: | The S4 Screw System™ components are manufactured from titanium alloy<br>(Ti-6Al-4V per ASTM F136). |
| Primary Predicate: | Acumed Cannulated Screw System (Acumed LLC. – K123890) |
| Additional Predicate: | Arthrex Compression FT Screws (Arthrex, Inc. - K132217) |
| Performance Data: | Mechanical testing of the worst case S4 Screw System™ and a predicate<br>component included torsion, insertion and pushout according to ASTM<br>F543. The mechanical test results demonstrated that S4 Screw System™<br>performance is substantially equivalent to the predicate devices.<br>In addition, bacterial endotoxin testing was performed and the implants<br>were found to meet the specified pyrogenicity limit. |
| Technological<br>Characteristics: | The S4 Screw System™ possesses similar technological characteristics as<br>one or more of the predicate devices. These include:<br>• performance (as described above),<br>• basic design (cannulated, headless screws) and<br>• implant materials (titanium alloy).<br>Differences between the subject and predicate devices did not raise new<br>questions of safety and effectiveness. Therefore the fundamental scientific<br>technology of the S4 Screw System™ is similar to previously cleared<br>devices. |
| Conclusion: | The S4 Screw System™ possesses the same intended use and similar<br>technological characteristics as the predicate devices. Therefore the S4<br>Screw System™ is substantially equivalent for its intended use. |