TMC Implant Fixation System
Device Facts
| Record ID | K262963 |
|---|---|
| Device Name | TMC Implant Fixation System |
| Applicant | Treace Medical Concepts, Inc. |
| Product Code | HRS · Orthopedic |
| Decision Date | Sep 15, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The TMC Implant Fixation System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in pediatric (aged >12 years-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples: •Osteotomy of the 1st and/or 5th Metatarsals for the treatment of deformity (e.g., hallux valgus,hallux rigidus, hallux limitus, tailor's bunion) such as: - Opening base wedge osteotomy - Closing base wedge osteotomy - Crescentic osteotomy - Proximal Chevron osteotomy - Distal Chevron osteotomy (Austin) - Transverse osteotomy •Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis •First metatarsal fracture fixation •Flatfoot Osteotomies - Lateral Column Lengthening (Evans Osteotomy) - Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) •Mid / Flatfoot Fusions - LisFranc Arthrodesis and/or Stabilization - Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - Talo-Navicular (TN) Fusion - Calcaneo-Cuboid (CC) Fusion - Medial Column Fusion
Device Story
TMC Implant Fixation System comprises metallic bone fixation hardware including straight, L-shaped, H-shaped, and anatomically curved plates, intramedullary plates, and cannulated/non-cannulated locking and non-locking screws. Used by orthopedic surgeons in clinical settings for foot surgery; provides mechanical stabilization of bone segments during healing of fractures, osteotomies, or fusions. Implants are surgically implanted to maintain bone alignment and compression. Benefits include structural support for bone reconstruction and deformity correction.
Clinical Evidence
Bench testing only. Mechanical construct testing and engineering analysis performed per ASTM F382 and ASTM F543, including static and dynamic 4-point bend testing, static torsion, driving torque, removal torque, and axial pullout analysis. No clinical data presented.
Technological Characteristics
Materials: Implant grade titanium alloy (Ti6Al4V-ELI) per ASTM F136. Components: Plates (straight, L, H, curved, intramedullary) and screws (2.5-3.3 mm diameter, 10-36 mm length). Sterilization: Gamma irradiation. No software, wireless, or electronic components.
Indications for Use
Indicated for stabilization of fresh fractures, revision procedures, joint fusion, and foot reconstruction in pediatric (>12-21 years) and adult (≥22 years) patients. Specific applications include metatarsal osteotomies, TMT/MTP joint arthrodesis, fracture fixation, flatfoot osteotomies, and mid/flatfoot fusions.
Regulatory Classification
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
- Treace Medical Concepts (TMC) Implant Fixation System (K251135)
- Wright Medical Technology Inc., PROSTEP™ TBI™ (Tailors Bunion Implant) System (K190970)
Submission Summary (Full Text)
{0}
**FDA** U.S. FOOD & DRUG
ADMINISTRATION
September 15, 2026
Treace Medical Concepts, Inc.
Melissa Coloroso
Principal Regulatory Affairs Specialist
100 Palmetto Park Pl.
Ponte Vedra, Florida 32081
Re: K262963
Trade/Device Name: TMC Implant Fixation System
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
Regulatory Class: Class II
Product Code: HRS, JDR, HWC
Dated: August 24, 2026
Received: August 25, 2026
Dear Melissa Coloroso:
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.
{1}
K262963 - Melissa Coloroso
Page 2
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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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-
{2}
K262963 - Melissa Coloroso
Page 3
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,
Thomas Mcnamara -S
For: Christopher Ferreira, M.S.
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
{3}
# 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. | | K262963 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| TMC Implant Fixation System | | | |
| Please provide your Indications for Use below. | | | ? |
| The TMC Implant Fixation System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in pediatric (aged >12 years-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples: •Osteotomy of the 1st and/or 5th Metatarsals for the treatment of deformity (e.g., hallux valgus,hallux rigidus, hallux limitus, tailor's bunion) such as: - Opening base wedge osteotomy - Closing base wedge osteotomy - Crescentic osteotomy - Proximal Chevron osteotomy - Distal Chevron osteotomy (Austin) - Transverse osteotomy •Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis •First metatarsal fracture fixation •Flatfoot Osteotomies - Lateral Column Lengthening (Evans Osteotomy) - Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) •Mid / Flatfoot Fusions - LisFranc Arthrodesis and/or Stabilization - Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - Talo-Navicular (TN) Fusion - Calcaneo-Cuboid (CC) Fusion - Medial Column Fusion | | | |
| Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | |
{4}
TREACE
Medical Concepts, Inc.
A Step Ahead in Foot and Ankle Surgery
Treace Medical Concepts (TMC) Implant Fixation System
Special 510(k) Premarket Notification
K262963
Page 1
### 510(k) Summary
Treace Medical Concepts (TMC) Medical Concepts Implant Fixation System
September 09, 2026
| Company: | Treace Medical Concepts, Inc. 100 Palmetto Park Place Ponte Vedra, FL 32081 |
| --- | --- |
| Establishment Registration: | 3011623994 |
| Primary Contact: | Melissa Coloroso, Principal Regulatory Affairs Specialist Phone: 303-641-8592 Fax: 904-834-7169 Email: mcoloroso@treace.net |
| Secondary Contact: | Kristina Hall, Sr. Director, Regulatory Affairs Phone: 904-373-5940 ext. 1321 Fax: 904-834-7169 Email: khall@treace.net |
| Trade Name: | Treace Medical Concepts (TMC) Implant Fixation System |
| Common Name: | Primary: Plate, fixation, bone Subsequent: Staple, fixation, bone; Screw, fixation, bone |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3030 21 CFR 888.3040 |
| Panel: | 87- Orthopedic |
| Product Code(s): | Primary: HRS Subsequent: JDR, HWC |
### Predicate Device(s):
Primary Predicate:
- Treace Medical Concepts (TMC) Implant Fixation System (K251135, S.E. 08/21/2025)
Additional Predicates:
- Wright Medical Technology Inc., PROSTEP™ TBI™ (Tailors Bunion Implant) System (K190970, S.E. 08/13/2019)
### Device Description:
Treace Medical Concepts (TMC) Implant Fixation System includes straight, L-shaped, H-shaped, anatomically curved plates, intramedullary plates, cannulated and non-cannulated compression implants, and associated instruments. It includes 2.5 mm, 2.7 mm, 3.0 mm and 3.3 mm diameter cannulated and non-cannulated, locking, and non-locking screws in lengths ranging from 10-36 mm. All implantable components are manufactured from implant grade titanium alloy (Ti6Al4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
{5}
TREACE
Medical Concepts, Inc.
A Step Ahead in Foot and Ankle Surgery
Treace Medical Concepts (TMC) Implant Fixation System
Special 510(k) Premarket Notification
K262963
Page 2
The changes described within this submission do not impact reprocessing, biocompatibility and sterility considerations in comparison to the predicate devices. The software, cybersecurity, EMC, and wireless technology sections are not applicable to the subject device.
## Indications for Use:
The TMC Implant Fixation System is intended for use for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in pediatric (aged >12 years-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples:
- Osteotomy of the 1st and/or 5th Metatarsals for the treatment of deformity (e.g., hallux valgus, hallux rigidus, hallux limitus, tailor's bunion) such as:
- Opening base wedge osteotomy
- Closing base wedge osteotomy
- Crescentic osteotomy
- Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin)
- Transverse osteotomy
- Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and / or arthritis
- First metatarsal fracture fixation
- Flatfoot Osteotomies
- Lateral Column Lengthening (Evans Osteotomy)
- Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
- Mid / Flatfoot Fusions
- LisFranc Arthrodesis and/or Stabilization
- Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion
- Medial Column Fusion
## Substantial Equivalence:
The primary predicate, the Treace Medical Concepts (TMC) Implant Fixation System (K251135, S.E. 08/21/2025), provides substantial equivalence to the subject TMC Implant Fixation System regarding identical intended use, materials, packaging, and similar overall design. The subject TMC Implant Fixation System is substantially equivalent to the additional predicate the PROSTEP™ TBI™ (Tailors Bunion Implant) System (K190970, S.E. 08/13/2019) given similar intended use, technology, materials, and mechanical performance.
The subject and predicate device are manufactured from implant grade titanium alloy (Ti6Al4V-ELI) per ASTM F136 and are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The technological differences between the subject and predicate devices include geometric modifications. Compared to the additional predicate, the subject device differs because it contains a cannulated and threaded intramedullary post. Any differences in the technological characteristics of the subject device when compared to
{6}
TREACE
Medical Concepts, Inc.
A Step Ahead in Foot and Ankle Surgery
Treace Medical Concepts (TMC) Implant Fixation System
Special 510(k) Premarket Notification
K262963
Page 3
the predicate devices do not raise any new questions of safety and effectiveness. Thus, it can be concluded that the subject device is substantially equivalent to the predicate device.
### Performance Testing:
Mechanical construct testing and analysis including static and dynamic 4-point bend testing and static torsion, driving torque, removal torque, and axial pullout engineering analysis based on ASTM F382 and ASTM F543 were performed between the subject and predicate plating systems. Further, engineering analysis of the worst-case cross-sections and geometries on the subject and predicate devices was performed. The mechanical testing, engineering analysis, cross-sectional, and geometrical analysis demonstrated that the subject devices did not present a new worst-case with regards to mechanical performance per ASTM F382 and ASTM F543 when compared to their predicate devices. The subject devices are substantially equivalent to the predicate devices.
### Conclusion:
The subject Treace Medical Concepts (TMC) Implant Fixation System has similar intended use, overall design, materials and mechanical properties to the predicate devices as demonstrated through bench testing and engineering analysis. Therefore, it can be concluded that the subject devices are at least safe and effective as and are substantially equivalent to the predicate devices.
