Ultra™ Compression Screw System

K251555 · Pace Surgical · HWC · Nov 6, 2025 · Orthopedic

Device Facts

• Record ID: K251555
• Device Name: Ultra™ Compression Screw System
• Applicant: Pace Surgical
• Product Code: HWC · Orthopedic
• Decision Date: Nov 6, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pace Surgical Ultra™ Compression Screw System is intended for the internal fixation and stabilization of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle. The System is specifically indicated for: Fractures and Osteotomies - Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc) - Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture) - Talar fractures - Ankle fractures - Navicular fractures - Fractures of the fibula, malleolus, and calcaneus - Metatarsal and phalangeal osteotomies - Weil osteotomy - Calcaneal osteotomy Fusion resulting from neuropathic osteoarthopathy (Charcot), example: - Medial and lateral column - Subtalar, talonavicular, and calcaneocuboid Arthrodesis and Deformity Correction - 1st MTP arthrodesis - Metatarsal deformity correction - Tarsometatarsal joint arthrodesis - Naviculocuneiform joint arthrodesis - Talonavicular arthrodesis - Subtalar joint arthrodesis - Triple arthrodesis - Medial column arthrodesis - Subtalar joint distraction arthrodesis - Ankle arthrodesis - Lateralizing calcaneal osteotomy - Lateral column lengthening - Hammertoe Hallux Valgus Correction - Fixation of osteotomies (i.e. Akin, Scarf, Chevron) - Interphalangeal (IP) arthrodesis - Proximal, midshaft, or distal osteotomy - Lapidus arthrodesis

Device Story

Ultra Compression Screw System provides internal fixation and stabilization for foot and ankle bone procedures. System comprises solid and cannulated screws (2-8mm diameter) in headed and headless variants, plus compatible washers. Used by orthopedic surgeons in clinical/OR settings to stabilize fractures, osteotomies, and arthrodeses. Device functions as mechanical fastener to maintain bone alignment during healing. Benefits include rigid fixation to support bone fusion and deformity correction.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing per ASTM F543 and compliance with FDA guidance 'Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway'.

Technological Characteristics

Metallic bone fixation fasteners (screws and washers). Materials: Titanium alloy per ASTM F136. Dimensions: 2-8mm diameter. Variants: Solid/cannulated, headed/headless, partial/fully threaded. Mechanical testing performed per ASTM F543.

Indications for Use

Indicated for internal fixation and stabilization of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle in patients requiring bone fixation.

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

• Monster Screw System (K203011)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

November 6, 2025

Pace Surgical
% Danielle Besal
Regulatory Consultant
MRC Global
9085 E. Mineral Circle, Suite 110
Centennial, Colorado 80112

Re: K251555
Trade/Device Name: Ultra™ Compression Screw System
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener
Regulatory Class: Class II
Product Code: HWC, HTN
Dated: October 10, 2025
Received: October 10, 2025

Dear Danielle Besal:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251555 - Danielle Besal
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251555 - Danielle Besal
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assistance/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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Ultra Compression Screw System
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K251555 | ? |
| Please provide the device trade name(s). | | ? |
| Ultra™ Compression Screw System | | |
| Please provide your Indications for Use below. | | ? |
| The Pace Surgical Ultra™ Compression Screw System is intended for the internal fixation and stabilization
of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle. The System is specifically
indicated for: | | |
| Fractures and Osteotomies
- Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
- Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
- Talar fractures
- Ankle fractures
- Navicular fractures
- Fractures of the fibula, malleolus, and calcaneus
- Metatarsal and phalangeal osteotomies
- Weil osteotomy
- Calcaneal osteotomy | | |
| Fusion resulting from neuropathic osteoarthopathy (Charcot), example:
- Medial and lateral column
- Subtalar, talonavicular, and calcaneocuboid | | |
| Arthrodesis and Deformity Correction
- 1st MTP arthrodesis
- Metatarsal deformity correction
- Tarsometatarsal joint arthrodesis
- Naviculocuneiform joint arthrodesis
- Talonavicular arthrodesis
- Subtalar joint arthrodesis
- Triple arthrodesis
- Medial column arthrodesis
- Subtalar joint distraction arthrodesis
- Ankle arthrodesis
- Lateralizing calcaneal osteotomy
- Lateral column lengthening
- Hammertoe | | |
| Hallux Valgus Correction
- Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
- Interphalangeal (IP) arthrodesis
- Proximal, midshaft, or distal osteotomy
- Lapidus arthrodesis | | |

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Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Ultra Compression Screw System
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K251555

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| 510(k) #: K251555 | 510(k) Summary | Prepared on: 2025-10-10 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Pace Surgical | |
| Applicant Address | 7 Great Valley Parkway, Suite 295 Malvern PA 19355 United States | |
| Applicant Contact Telephone | 610-952-0462 | |
| Applicant Contact | Bill Rhoda | |
| Applicant Contact Email | [e-mail] | |
| Correspondent Name | MRC Global | |
| Correspondent Address | 9085 E. Mineral Circle, Suite 110 Centennial CO 80112 United States | |
| Correspondent Contact Telephone | 9018278670 | |
| Correspondent Contact | Danielle Besal | |
| Correspondent Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Ultra Compression Screw System | |
| Common Name | Smooth or threaded metallic bone fixation fastener | |
| Classification Name | Screw, Fixation, Bone | |
| Regulation Number | 888.3040 | |
| Product Code(s) | HWC, HTN | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K203011 | Monster Screw System | HWC |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The Ultra Compression Screw System is intended for the internal fixation and stabilization of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle. The system consists of various solid and cannulated screws in diameters ranging from 2-8mm with partial and fully threaded variants. Screws are available in headed and headless variants. Compatible washers are also included in the system. All screws and washers are manufactured from titanium alloy per ASTM F136. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| The Pace Surgical Ultra™ Compression Screw System is intended for the internal fixation and stabilization of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle. The System is specifically indicated for: | | |

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K251555

Fractures and Osteotomies
- Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
- Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
- Talar fractures
- Ankle fractures
- Navicular fractures
- Fractures of the fibula, malleolus, and calcaneus
- Metatarsal and phalangeal osteotomies
- Weil osteotomy
- Calcaneal osteotomy

Fusion resulting from neuropathic osteoarthopathy (Charcot), example:
- Medial and lateral column
- Subtalar, talonavicular, and calcaneocuboid

Arthrodesis and Deformity Correction
- 1st MTP arthrodesis
- Metatarsal deformity correction
- Tarsometatarsal joint arthrodesis
- Naviculocuneiform joint arthrodesis
- Talonavicular arthrodesis
- Subtalar joint arthrodesis
- Triple arthrodesis
- Medial column arthrodesis
- Subtalar joint distraction arthrodesis
- Ankle arthrodesis
- Lateralizing calcaneal osteotomy
- Lateral column lengthening
- Hammertoe

Hallux Valgus Correction
- Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
- Interphalangeal (IP) arthrodesis
- Proximal, midshaft, or distal osteotomy
- Lapidus arthrodesis

| Indications for Use Comparison | 21 CFR 807.92(a)(5) |
| --- | --- |

The subject and predicate devices have the same intended use of bone fixation and stabilization. The minor differences in the indications for use statement does not impact its intended use. In addition, the specific indication examples are identical to the predicate.

| Technological Comparison | 21 CFR 807.92(a)(6) |
| --- | --- |

The subject device is similar in technological characteristics to the predicate device. The materials are similar to the predicate and the geometry and sizing are within the predicate device offerings.

| Non-Clinical and/or Clinical Tests Summary & Conclusions | 21 CFR 807.92(b) |
| --- | --- |

Mechanical testing per ASTM F543 was conducted on the subject devices.

Clinical data were not applicable.

The subject devices met the performance criteria specified in FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway;" therefore, can be considered substantially equivalent to the predicate device.

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