Who is the manufacturer of Fracture and Correction System?

In2bones USA, LLC filed the 510(k) submission for Fracture and Correction System (K180377).

What is the FDA product code for Fracture and Correction System?

HWC. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Fracture and Correction System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Fracture and Correction System?

In2Bones Fracture and Correction System (K170518); AutoFix Screws (K052576); IBS 2.0mm Screws (K160174); Wright Medical Cannulated Screw System (K143460).

Who can help prepare an FDA 510(k) submission like Fracture and Correction System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Fracture and Correction System

K180377 · In2bones USA, LLC · HWC · Jun 20, 2018 · Orthopedic

Device Facts

Record ID	K180377
Device Name	Fracture and Correction System
Applicant	In2bones USA, LLC
Product Code	HWC · Orthopedic
Decision Date	Jun 20, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures and non-unions of the 5th metatarsal. The Fracture and Correction System lag screws are intended to be used as screws, or in a plate-screw system for internal bone fraction for bone fractures, fusionies and non-unions of various bones, including humerus, radius, uha, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).

Device Story

System of titanium alloy plates, screws, and surgical instruments for orthopedic fracture fixation and reconstruction. Subject of submission: addition of smaller diameter CoLag™ screws and modified tip design for existing lag screws. Used by surgeons in clinical settings for internal bone fixation. Provides mechanical stabilization of bone segments to facilitate healing of fractures, fusions, and osteotomies. Output is physical fixation of bone; no electronic or software-based output. Benefits include restoration of bone alignment and stability.

Clinical Evidence

Bench testing only. Performance testing included insertion/removal testing, static pull-out testing, and torque capacity testing per ASTM F543. LAL endotoxin testing performed on each implant batch. No clinical data provided.

Technological Characteristics

Metallic bone fixation fasteners (plates and screws). Material: Titanium Alloy (ASTM F136). Dimensions: 2.0mm to 6.7mm diameters, 8mm to 115mm lengths. Mechanical fixation principle. No energy source. Non-software device.

Indications for Use

Indicated for patients requiring internal bone fixation for fractures, fusions, osteotomies, and non-unions of the 5th metatarsal, humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, phalanges).

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

In2Bones Fracture and Correction System (K170518)
AutoFix Screws (K052576)
IBS 2.0mm Screws (K160174)
Wright Medical Cannulated Screw System (K143460)

Related Devices

K181843 — MLP Special Locking Bone Plate System · Maxxion Medical, LLC / Baumer SA · Mar 4, 2019
K200398 — AxSOS 3 AF System and AxSOS 3 Ti System · Stryker GmbH · Jun 5, 2020
K230744 — Acumed Acutrak 3 Headless Compression Screw System · Acumed, LLC · Jun 9, 2023
K131324 — MAXTORQUE SCREW SYSTEM · Orthohelix Surgical Designs, Inc. · May 31, 2013
K170887 — EVOS Small Fragment Plating System · Smith & Nephew, Inc. · Apr 24, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ June 20, 2018 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. In2Bones USA, LLC % Christine Scifert Executive Vice President MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis, Tennessee 38119 Re: K180377 Trade/Device Name: Fracture and Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: May 14, 2018 Received: May 16, 2018 Dear Christine Scifert: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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. {1}------------------------------------------------ K180377 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K180377 ## Device Name In2Bones Fracture and Correction System #### Indications for Use (Describe) The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures and non-unions of the 5th metatarsal. The Fracture and Correction System lag screws are intended to be used as screws, or in a plate-screw system for internal bone fraction for bone fractures, fusionies and non-unions of various bones, including humerus, radius, uha, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges). Type of Use (Select one or both, as applicable) X 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) {3}------------------------------------------------ # 510(k) Summary # In2Bones Fracture and Correction System June 18, 2018 | Company: | In2Bones USA, LLC 6060 Poplar Ave, Suite 380 Memphis, TN 38119 901-260-7931 | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact: | Christine Scifert | | Company Contact: | Rebecca Wahl | | Trade Name: | Fracture and Correction System | | Common Name: | Screw, Fixation, Bone Plate, Fixation, Bone | | Classification: | II | | Regulation Number: | 888.3040 - Smooth or threaded metallic bone fixation fastener 888.3030 - Single/multiple component metallic bone fixation appliances and accessories | | Panel: | 87-Orthopedic | | Product Code(s): | HWC, HRS | Device Description: The In2Bones Fracture and Correction System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities. The scope of this submission is to add smaller diameter CoLag™ Screws as well as a version of all lag screws within the system that has a modified tip design. All screws are manufactured from Titanium Alloy conforming to ASTM F136. The In2Bones USA LLC, Fracture and Correction System plates and screws are Indications for Use: intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal. The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges). {4}------------------------------------------------ Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA: Primary Predicate . K170518 – In2Bones Fracture and Correction System Additional Predicates - K052576 AutoFix Screws . - K160174 IBS 2.0mm Screws . - K143460 Wright Medical Cannulated Screw System . See below for a comparison table of the subject and predicate devices. | Device | In2Bones Fracture and Correction System CoLag™ Screws (Subject Device) | In2Bones Fracture and Correction System (K170518) | AutoFix Screws (K052576) | IBS 2.0mm Screws (K160174) | Wright Medical Cannulated Screw System (K143460) | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Fixation Screws | Fixation Plates and Screws | Fixation Screws | Fixation Screws | Fixation Screws | | Indications for Use | The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non- unions of the 5th metatarsal. The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges). | The In2Bones USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non- unions of the 5th metatarsal. The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges). | The SBi AutoFIX Twin Pitch Cannulated Compression Screw System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small bones. | The IBS 2.0 Osteosynthesis screws are intended for: - The fixation of arthrodesis, osteotomies or fractures of small bones of the upper and lower limbs - Osteosynthesis requiring mono or bicortical compression The size of the chosen screw should be adapted to the specific indications. | The CSS cannulated bone screw is indicated for bone fractures, osteotomies, arthodeses, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine. | | Product Code | HRS, HWC | HRS, HWC | HWC | HWC | HWC | | Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Stainless Steel | Titanium Alloy (ASTM F136) | Titanium Alloy | | Geometry and Dimensions | 2.0mm, 8-55mm Length 2.5mm, 8-10mm Length 2.5mm, 8-55mm Length 3.0mm, 12-40mm Length 4.0mm, 20-60mm Length 5.0mm, 30-70mm Length 6.7mm, 30-115mm Length | 2.5mm, 12-30mm Length 3.0mm, 12-40mm Length 4.0mm, 20-60mm Length 5.0mm, 30-70mm Length 6.7mm, 30-115mm Length | 2.0mm, 10-30mm Length 2.5mm 10-30mm Length 3.0mm 12-40mm Length 4.0mm 20-50mm Length 6.5mm 45-100mm Length | 2.0mm, 10-30mm Length | 2.0mm, 7-50mm Length 2.5mm, 10-50mm Length 3.0mm, 12-50mm Length 3.5mm, 12-50mm Length 4.0mm, 14-50mm Length | {5}------------------------------------------------ The subject Fracture and Correction System components have been demonstrated to be substantially equivalent to the previously cleared devices cleared under K170518, K052576, K160174, and K143460 as the products are similar in indications, materials and geometry. Performance Testing / Rationales: Insertion/Removal Testing, Static Pull-out Testing, and Torque Capacity Testing per ASTM F543 demonstrated that the subject device is substantially equivalent to the predicate. The implants and instruments that are the submission were determined not to be worst case and were adopted into previous validations conducted for biocompatibility, cleaning, sterilization and packaging. LAL endotoxin testing was confirmed to be conducted on each implant batch. ## Conclusion Based on the test results, nonclinical tests and rationales and the comparison to the predicate devices, the subject device is as safe and as effective and performs as well as or better than the legally marketed predicates and therefore is determined to be substantially equivalent to the predicate devices.