(128 days)
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).
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 provided document is a 510(k) summary for the In2Bones Fracture and Correction System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices through direct comparison of indications, materials, and geometry, as well as performance testing.
Crucially, this document describes a traditional medical device (bone fixation system) and not an AI/ML-driven medical device. Therefore, the concepts of acceptance criteria for AI model performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to this submission.
The document demonstrates equivalence based on:
- Indications for Use: The subject device has similar intended uses for treating fractures, fusions, osteotomies, and non-unions of various bones, aligning with its predicate devices.
- Material: The device is made of Titanium Alloy (ASTM F136), which is consistent with the primary predicate and some additional predicates. One predicate uses Stainless Steel, but the overall material conformity is deemed acceptable.
- Geometry and Dimensions: The subject device introduces smaller diameter CoLag™ Screws and a modified tip design but remains within the range of dimensions and geometries of the predicate devices.
- Performance Testing: Non-clinical tests were conducted:
- Insertion/Removal Testing
- Static Pull-out Testing
- Torque Capacity Testing (per ASTM F543)
These tests confirmed that the subject device performs substantially equivalently to the predicate.
Therefore, I cannot provide the requested information about AI/ML acceptance criteria and study details because the provided text describes a physical medical device clearance, not an AI/ML device.
If you have a document pertaining to an AI/ML medical device, please provide it, and I will gladly describe its acceptance criteria and study details based on that information.
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June 20, 2018
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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.
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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
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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)
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510(k) Summary
In2Bones Fracture and Correction System June 18, 2018
| Company: | In2Bones USA, LLC6060 Poplar Ave, Suite 380Memphis, TN 38119901-260-7931 |
|---|---|
| Primary Contact: | Christine Scifert |
| Company Contact: | Rebecca Wahl |
| Trade Name: | Fracture and Correction System |
| Common Name: | Screw, Fixation, BonePlate, Fixation, Bone |
| Classification: | II |
| Regulation Number: | 888.3040 - Smooth or threaded metallic bone fixation fastener888.3030 - Single/multiple component metallic bone fixation appliances andaccessories |
| 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).
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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 andCorrection System CoLag™Screws(Subject Device) | In2Bones Fracture andCorrection System(K170518) | AutoFix Screws(K052576) | IBS 2.0mm Screws(K160174) | Wright MedicalCannulated Screw System(K143460) |
|---|---|---|---|---|---|
| IntendedUse | Fixation Screws | Fixation Plates and Screws | Fixation Screws | Fixation Screws | Fixation Screws |
| Indicationsfor Use | The In2Bones USA LLC,Fracture and CorrectionSystem plates and screwsare intended to treatfractures, fusions,osteotomies and non-unions of the 5thmetatarsal.The Fracture andCorrection System lagscrews are intended to beused as stand-alone bonescrews, or in a plate-screwsystem for internal bonefixation for bone fractures,fusions, osteotomies andnon-unions of variousbones, including humerus,radius, ulna, tibia,calcaneus, fibula, and smallbones (metacarpals,metatarsals, andphalanges). | The In2Bones USA LLC,Fracture and CorrectionSystem plates and screwsare intended to treatfractures, fusions,osteotomies and non-unions of the 5thmetatarsal.The Fracture andCorrection System lagscrews are intended to beused as stand-alone bonescrews, or in a plate-screwsystem for internal bonefixation for bone fractures,fusions, osteotomies andnon-unions of variousbones, including humerus,radius, ulna, tibia,calcaneus, fibula, and smallbones (metacarpals,metatarsals, andphalanges). | The SBi AutoFIX TwinPitch CannulatedCompression ScrewSystem implants areindicated in the treatmentof fractures, non-unions,pseudoarthrosis anddegenerative changes aswell as correctiveosteotomies gearedtowards a functionallystable osteosynthesis insmall bones. | The IBS 2.0Osteosynthesisscrews are intendedfor:- The fixation ofarthrodesis,osteotomies orfractures of smallbones of the upperand lower limbs- Osteosynthesisrequiring mono orbicorticalcompressionThe size of thechosen screw shouldbe adapted to thespecific indications. | The CSS cannulated bonescrew is indicated forbone fractures,osteotomies, arthodeses,osteochronditis andtendonreattachment. Thesescrews are not intendedfor attachment or fixationto the posterior elements(pedicles) of cervical,thoracic, or lumbar spine. |
| ProductCode | HRS, HWC | HRS, HWC | HWC | HWC | HWC |
| Material | Titanium Alloy (ASTMF136) | Titanium Alloy (ASTM F136) | Stainless Steel | Titanium Alloy (ASTMF136) | Titanium Alloy |
| GeometryandDimensions | 2.0mm, 8-55mm Length2.5mm, 8-10mm Length2.5mm, 8-55mm Length3.0mm, 12-40mm Length4.0mm, 20-60mm Length5.0mm, 30-70mm Length6.7mm, 30-115mm Length | 2.5mm, 12-30mm Length3.0mm, 12-40mm Length4.0mm, 20-60mm Length5.0mm, 30-70mm Length6.7mm, 30-115mm Length | 2.0mm, 10-30mm Length2.5mm 10-30mm Length3.0mm 12-40mm Length4.0mm 20-50mm Length6.5mm 45-100mm Length | 2.0mm, 10-30mmLength | 2.0mm, 7-50mm Length2.5mm, 10-50mm Length3.0mm, 12-50mm Length3.5mm, 12-50mm Length4.0mm, 14-50mm Length |
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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.
§ 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.