(111 days)
The TriMed® Small Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot.
The TriMed® Large Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of large bones and large bone fragments in the hand, wrist, elbow, ankle, and foot.
TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium. The small screws are indicated to be used as an aid in fracture fixations, non-unions and osteotomies of small bones and small bone fragments; the large screws are indicated to be used in fracture fixations, non-unions and osteotomies of large bones and large bone fragments. The TriMed Compression Screws are designed to provide additional constraint of movement of a fractured/osteotomized bone and non-unions and are intended only as an aid to fix the fracture/osteotomy in place during the healing process.
Based on the provided FDA 510(k) Clearance Letter for TriMed® Compression Screws (K243943), here's an analysis of the acceptance criteria and the study proving the device meets them.
It's important to note that this document is for a physical medical device (compression screws), not an AI/software-as-a-medical-device (SaMD). Therefore, many of the typical criteria for AI/ML-based devices (such as ground truth establishment by experts, adjudication, MRMC studies, standalone algorithm performance, training/test set sample sizes for AI, etc.) are not applicable here.
The "study" in this context refers to mechanical testing to demonstrate the device's performance and substantial equivalence to predicate devices, rather than clinical studies with human subjects or AI model validation.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for bone fixation fasteners like the TriMed® Compression Screws are primarily related to their mechanical properties, material biocompatibility, and intended use as compared to "predicate" devices already on the market. The core concept for a 510(k) clearance is "substantial equivalence."
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category/Type | Description of Acceptance Criteria | Reported Device Performance / Evidence of Meeting Criteria |
|---|---|---|
| Mechanical Performance | The device must meet established performance standards for bone screws, demonstrating adequate strength, fatigue resistance, and functional integrity for its intended use (fracture fixation, non-unions, osteotomies). This is typically assessed against recognized industry standards and direct comparison to predicate devices. | "Mechanical testing on TriMed Compression Screws was conducted in accordance with ASTM F543-17, FDA Guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, and/or in comparison to compression screws cleared under predicates K050681 and K093676." The submission implies successful completion of these tests, leading to the substantial equivalence determination. |
| Material Compatibility | The materials used (medical grade stainless steel and titanium) must be biocompatible and suitable for long-term implantation in the human body. | "TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium." The use of "medical grade" materials and comparison to predicate devices (some using stainless steel and titanium, others titanium only) implies conformance to established material safety standards. |
| Design and Principles of Operation | The device's design features, principles of operation, and manufacturing processes should be substantially equivalent to legally marketed predicate devices, ensuring similar safety and effectiveness profiles. | "TriMed Compression Screws are substantially equivalent to the predicate devices in terms of design features, principles of operation, manufacturing, packaging, and labeling." The document specifically discusses the introduction of additional materials (stainless steel) and new screw diameters/lengths, asserting that these differences are "minor and do not raise different questions concerning safety or effectiveness." |
| Intended Use / Indications for Use | The stated indications for use for the device must align with historical use of similar devices and be supported by the device's design and performance. | TriMed® Compression Screws are indicated for "fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot" (Small Screws) and "large bones and large bone fragments" (Large Screws). This aligns with the use of predicate bone fixation fasteners. |
| Predetermined Change Control Plan (PCCP) | The PCCP outlines pre-approved modifications and the testing required to ensure continued safety and effectiveness without requiring new 510(k)s. This demonstrates a proactive approach to managing changes. | The PCCP details planned modifications (new materials, screw head designs, headed screw line extension) and specifies the test methods and validation activities (e.g., ASTM F543-17, FDA guidance, IEC 62366-1) that will be performed for each change. |
Study Details (as applicable to a physical medical device)
1. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of human data. For mechanical testing, this refers to the number of components or devices tested. ASTM F543-17 would specify the required number of samples for each mechanical test (e.g., torsional strength, bending strength, fatigue).
- Data Provenance: The document focuses on performance testing (mechanical studies) rather than clinical data from patients. The testing was conducted "in accordance with ASTM F543-17, FDA Guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, and/or in comparison to compression screws cleared under predicates K050681 and K093676." This implies the data is generated from laboratory testing of the manufactured devices. No country of origin for data (like patient data) is relevant here, as it's product engineering test data. It's prospective data generation from in vitro testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable (N/A). This is a physical medical device, not an AI/SaMD. "Ground truth" is established by engineering standards (e.g., ASTM F543-17) and direct comparison to the physical properties of predicate devices. The "experts" would be the engineers and scientists conducting the mechanical tests and comparing the results to the specified performance criteria, but their number and specific qualifications for "ground truth" establishment are not detailed in the context of expert consensus on an image or clinical finding.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical/imaging studies, typically for AI models. For mechanical testing, the results are quantitative and objective, measured against predefined standards.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable (N/A). MRMC studies are specific to evaluating the clinical performance of diagnostic or AI-assisted devices with human readers interpreting cases. This device is a surgical implant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable (N/A). This criterion is for AI algorithms. The "standalone performance" of these screws refers to their mechanical integrity without human interaction, which is assessed through the mechanical testing mentioned.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Standards and Predicate Device Performance Data. For a physical implant, "ground truth" for clearance is based on adherence to recognized mechanical engineering standards (e.g., ASTM F543-17) and demonstrating that the device performs equivalently or better than, and poses no new safety concerns compared to, the already cleared predicate devices.
7. The sample size for the training set:
- Not Applicable (N/A). This question is for AI/ML models. There is no "training set" in the context of clearing a physical medical device. The "training" for the device would be its design and manufacturing process, optimized through engineering principles.
8. How the ground truth for the training set was established:
- Not Applicable (N/A). As there's no training set for an AI model, this question is irrelevant here. The design and manufacturing of the screws are based on established biomechanical principles and material science.
In summary, the 510(k) clearance for the TriMed® Compression Screws relies on demonstrating substantial equivalence to predicate devices through a combination of engineering design comparisons, material characterization, and rigorous mechanical performance testing according to well-established standards. The typical criteria for AI/ML devices do not apply to this type of traditional medical device.
FDA 510(k) Clearance Letter - TriMed® Compression Screws
Page 1
April 10, 2025
TriMed, Inc.
Thomas Arnold
Sr. Regulatory Affairs Specialist
27533 Avenue Hopkins
Santa Clarita, California 91355
Re: K243943
Trade/Device Name: TriMed® Compression Screws
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener
Regulatory Class: Class II
Product Code: HWC
Dated: December 20, 2024
Received: December 20, 2024
Dear Thomas Arnold:
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.
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K243943 - Thomas Arnold Page 2
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
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
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K243943 - Thomas Arnold Page 3
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-assistance/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 -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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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K243943
Device Name
TriMed® Compression Screws
Indications for Use (Describe)
The TriMed® Small Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot.
The TriMed® Large Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of large bones and large bone fragments in the hand, wrist, elbow, ankle, and foot.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Corporate Office
27533 Avenue Hopkins
Valencia, CA 91355
800-633-7221 Phone
661-255-7406 Office
661-254-8485 Fax
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.92.
Submitter Information 21 CFR 807.92(a)(1)
Submitter: TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita, CA 91355 USA
Phone: 1-661-255-7406
Establishment Registration Number: 2031009
Contact Person: Thomas Arnold
Sr. Regulatory Affairs Specialist
Phone: 1-661-255-7406
Email: thomas.arnold@henryschein.com
Date Prepared: December 20, 2024
Device Information 21 CFR 807.92(a)(2)
Trade Name: TriMed® Compression Screws
Common Name: Screw, Fixation, Bone
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener
Classification: Class II
Product Code: HWC
Review Panel: Orthopedic
Legally Marketed Predicate Device(s) 21 CFR 807.92(a)(3)
Device Trade Name: Omnitech Large, TriMed Compression Screw
510(k) Number: K093676 (Primary Predicate)
Product Code: HWC, HTY
Device Trade Name: Omnitech System & Easy Lock Osteosystem with Xtremities Plates
510(k) Number: K050681 (Secondary Predicate)
Product Code: HWC, HRS
K243943- page 1 of 5
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Corporate Office
27533 Avenue Hopkins
Valencia, CA 91355
800-633-7221 Phone
661-255-7406 Office
661-254-8485 Fax
Device Trade Name: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
510(k) Number: K161616 (Secondary Predicate)
Product Code: HWC
Device Description 21 CFR 807.92(a)(4)
TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium. The small screws are indicated to be used as an aid in fracture fixations, non-unions and osteotomies of small bones and small bone fragments; the large screws are indicated to be used in fracture fixations, non-unions and osteotomies of large bones and large bone fragments. The TriMed Compression Screws are designed to provide additional constraint of movement of a fractured/osteotomized bone and non-unions and are intended only as an aid to fix the fracture/osteotomy in place during the healing process.
Intended Use / Indications for Use 21 CFR 807.92(a)(5)
TriMed® Small Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot.
TriMed® Large Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of large bones and large bone fragments in the hand, wrist, elbow, ankle, and foot.
Comparison of Technological Characteristics 21 CFR 807.92(a)(6)
TriMed Compression Screws and the DePuy predicate devices are manufactured from stainless steel and titanium alloy, whereas the TriMed predicate devices are manufactured from titanium alloy only. The comparison to the secondary predicate, DePuy Synthes Compression Screws (K161616), supports the introduction of additional materials, as well as new screw diameters and lengths for the subject devices. TriMed Compression Screws are substantially equivalent to the predicate devices in terms of design features, principles of operation, manufacturing, packaging, and labeling. Any differences between the proposed device and the predicate devices are considered minor and do not raise different questions concerning safety or effectiveness.
K243943- page 2 of 5
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Corporate Office
27533 Avenue Hopkins
Valencia, CA 91355
800-633-7221 Phone
661-255-7406 Office
661-254-8485 Fax
Performance Data 21 CFR 807.92(b)
Mechanical testing on TriMed Compression Screws was conducted in accordance with ASTM F543-17, FDA Guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, and/or in comparison to compression screws cleared under predicates K050681 and K093676.
Conclusion
Based on the indications for use, technological characteristics, and the summary of data submitted, TriMed, Inc. has determined that the subject device does not raise different questions of safety and effectiveness compared to the predicate devices. Therefore, the proposed subject device is substantially equivalent to the legally marketed predicate devices.
Predetermined Change Control Plan (PCCP)
This submission includes a Predetermined Change Control Plan (PCCP) for TriMed Compression Screws, prepared in alignment with the FDA draft guidance, "Predetermined Change Control Plans for Medical Devices." The PCCP establishes a comprehensive framework for managing pre-planned modifications, including introducing new material options, screw head designs, and a line extension featuring headed screws. It also details the methods for implementing these modifications while ensuring the TriMed Compression Screws remain as safe and effective as the predicate device. A summary of the proposed modifications, testing methods, validation activities, and user communication is provided in the table below.
K243943- page 3 of 5
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Corporate Office
27533 Avenue Hopkins
Valencia, CA 91355
800-633-7221 Phone
661-255-7406 Office
661-254-8485 Fax
| Planned Modifications | Test Methods and Validation Activities | Communication to Users, as Needed |
|---|---|---|
| Addition of materials (stainless steel and titanium alloy) | Testing for safety and effectiveness will be performed in accordance with ASTM F543-17 and/or directly against FDA-cleared predicates.Verification and validation will be conducted in accordance with the requirements outlined in the Modification Protocol.When applicable, test methods will follow the recommendations in the most recent version of the FDA guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway. | Labeling will be updated in accordance with the authorized PCCP to provide users with current information regarding the device material composition. |
| Design change of screw head | Verification and validation will be conducted in accordance with the requirements outlined in the Modification Protocol, including adherence to IEC 62366-1.When applicable, test methods will follow the recommendations in the most recent version of the FDA guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway. | N/A. Devices are distributed in system-specific trays. Appropriate drivers will be provided in these trays to facilitate implantation. |
| Line extension featuring large headed screws | Testing for safety and effectiveness will be performed in accordance with ASTM F543-17 and/or directly against FDA-cleared predicates.Verification and validation will be conducted in accordance with the | Line extension will be communicated by means of IFUs and Surgical Techniques. |
K243943- page 4 of 5
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Corporate Office
27533 Avenue Hopkins
Valencia, CA 91355
800-633-7221 Phone
661-255-7406 Office
661-254-8485 Fax
| Planned Modifications | Test Methods and Validation Activities | Communication to Users, as Needed |
|---|---|---|
| requirements outlined in the Modification Protocol.When applicable, test methods will follow the recommendations in the most recent version of the FDA guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway. |
K243943- page 5 of 5
§ 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.