(128 days)
Not Found
No
The summary describes a system of plates and screws for bone fracture treatment and does not mention any AI or ML components or functionalities.
Yes
The device is described as "intended to treat fractures and non-unions" of various bones, which is a therapeutic purpose.
No
This device is a system of plates and screws and surgical instruments used to treat fractures and non-unions, which is a therapeutic rather than diagnostic function. It is used in the treatment part of patient care, not for diagnosing a condition.
No
The device description explicitly states it is a system of plates, screws, and surgical instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a system of plates, screws, and surgical instruments used for the internal fixation of bone fractures and non-unions. This is a surgical procedure performed directly on the body, not an examination of a specimen outside the body.
- Lack of IVD Indicators: The description does not mention any analysis of biological samples, laboratory testing, or diagnostic purposes related to analyzing bodily fluids or tissues.
The device described is a surgical implant system used for orthopedic procedures.
N/A
Intended Use / Indications for 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).
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).
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
5th metatarsal, humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metacarpals, metatarsals, and phalanges).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K170518, K052576, K160174, K143460
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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.