Haymaker® Screw System

K222799 · Orthocircle Spine D.B.A. OC Medical Devices · HWC · Jan 10, 2023 · Orthopedic

Device Facts

• Record ID: K222799
• Device Name: Haymaker® Screw System
• Applicant: Orthocircle Spine D.B.A. OC Medical Devices
• Product Code: HWC · Orthopedic
• Decision Date: Jan 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Haymaker® Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

Device Story

Haymaker® Screw System consists of type-II anodized fully threaded titanium (Ti-6Al-4V ELI) screws; features dual thread at proximal end for increased engagement; tapered design facilitates fit within intramedullary canals. Available in multiple lengths (from 25 mm) and diameters (Ø3.6 mm, Ø4.5 mm). System includes single-use sterile-packed instrumentation: guide wire, cannulated drill, and T-10 cannulated driver. Used by surgeons for small bone fracture fixation, non-union repair, and arthrodesis. Provides mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

Bench testing only. Testing included static driving and removal torque, torsional properties, and axial pullout per ASTM F543. Results demonstrate sufficient strength for intended use.

Technological Characteristics

Material: Type-II anodized titanium (Ti-6Al-4V ELI per ASTM F136). Design: Fully threaded, tapered, cannulated screw. Dimensions: Ø3.6 mm and Ø4.5 mm diameters; various lengths starting at 25 mm. Instrumentation: Single-use sterile guide wire, cannulated drill, T-10 cannulated driver. Mechanical testing: ASTM F543 (static driving/removal torque, torsional properties, axial pullout).

Indications for Use

Indicated for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid, carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head, and radial styloid.

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

• Innate Cannulated Screw System (K183603)
• ExoMed ITN Cannulated Screw System (K171558)
• Treace Medical Concepts (TMC) Compression Screw System (K172617)

Submission Summary (Full Text)

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January 10, 2023

OrthoCircle Spine d.b.a. OC Medical Devices % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K222799

Trade/Device Name: Haymaker® 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: December 12, 2022 Received: December 12, 2022

Dear Nathan Wright:

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.

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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 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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Shumaya Ali -S

Shumaya Ali, M.P.H. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K222799

Device Name

Haymaker® Screw System

Indications for Use (Describe)

The Haymaker® Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

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)

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# K222799 - 510(K) SUMMARY

| Submitter's Name: | OrthoCircle Spine D.B.A. OC Medical Devices |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 15 East Montgomery Crossroads, Suite 3<br>Savannah, GA 31406 |
| Submitter's Telephone: | 888-463-5803 |
| Contact Person: | Nathan Wright MS<br>Empirical Technologies<br>1-719-351-0248<br>[e-mail]<br>Image: Empirical Technologies Logo |
| Date Summary was Prepared: | December 12, 2022 |
| Trade or Proprietary Name: | Haymaker® Screw System |
| Common or Usual Name: | Smooth Or Threaded Metallic Bone Fixation Fastener |
| Classification: | Class II per 21 CFR §888.3040 |
| Product Code: | HWC |
| Classification Panel: | Orthopedic |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Haymaker® System includes type-II anodized fully threaded titanium (Ti-6Al-4V ELI per ASTM F136) screws which provides a dual thread at the proximal end of the screw, increasing engagement with the head and neck of the metacarpal or other small bones. A tapered design is intended to allow the screw to fit more comfortably through the narrowing of an intramedullary canal. Multiple lengths from 25 mm at 03.6 mm or Ø4.5 mm in diameter are offered for treatment of various shapes and sizes of small bones. Single use supplemental instrumentation is provided sterile packed, consisting of a guide wire, cannulated drill, and T-10 cannulated driver.

## INDICATIONS FOR USE

The Haymaker® Screw System is intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

#### TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are the same between the subject and predicates:

- Indications for Use
- Materials of manufacture
- Structural support mechanism
- Sizes

#### Predicate Devices

| 510k<br>Number | Trade or Proprietary or Model Name | Manufacturer | Product<br>Code | Predicate<br>Type |
|----------------|--------------------------------------------------------|-------------------------------|-----------------|-------------------|
| K183603 | Innate Cannulated Screw System | Exsomed Corporation | HWC | Primary |
| K171558 | ExoMed ITN Cannulated Screw System | ExsoMed Holdings Company, LLC | HWC | Additional |
| K172617 | Treace Medical Concepts (TMC) Compression Screw System | Treace Medical Concepts, Inc. | HWC | Additional |

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# Performance Data

The Haymaker® Screw System has been tested in the following test modes:

- Static Driving and Removal Torque per ASTM F543 ●
- Torsional Properties per ASTM F543 ●
- Axial Pullout per ASTM F543 ●

The results of this non-clinical testing show that the strength of the Haymaker® Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

#### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Haymaker® Screw System is substantially equivalent to the predicate device.