(71 days)
Not Found
No
The document describes a range extension and minor modifications to existing osteosynthesis screws, focusing on mechanical properties and dimensional comparisons. There is no mention of AI or ML technology.
Yes
The device is a screw intended for the fixation of arthrodesis, osteotomies, or fractures, which are procedures that treat or alleviate a disease or injury.
No
Explanation: The device is an osteosynthesis screw intended for fixation of bones. Its purpose is to physically stabilize and aid in the healing of fractures, osteotomies, or arthrodesis, not to diagnose a condition.
No
The device description clearly states it is a range extension of existing osteosynthesis screws, which are physical implants used in surgery. The modifications described are related to the physical dimensions and thread design of these screws.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs" and "Osteosynthesis requiring a mono or bicortical compression." This describes a surgical implant used directly on the body for structural support and repair.
- Device Description: The description details physical modifications to osteosynthesis screws, which are medical devices implanted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The I.B.S.TM compression and neutralization osteosynthesis screws are intended for:
- The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs
- Osteosynthesis requiring a mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The modified I.B.STM osteosynthesis screws are a range extension of the existing screw line cleared in K131920 I.B.STM osteosynthesis screw. The modification made on the I.B.S.TM osteosynthesis screw are: I.B.S.TM Osteosynthesis Compression Screw, diameter 6.5mm: - Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references; - Modification of the distal thread to a long distal thread for screws, with total length comprised between 60mm and 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Neutralization Screw, diameter 6.5mm: - Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Compression and Neutralization screw, diameter 2.5mm: - Range extension of the total screw length, with addition of length 30mm, and creation of dedicated references.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long or short bones of the upper and lower limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The dimensional modifications between the unmodified I.B.S.TM osteosynthesis Screws, K131920, and the modified I.B.S.TM osteosynthesis Screws have been evaluated through dimensional comparison with predicate devices and analysis of the impact on mechanical behavior based on standard ASTM F543. This standard describes methods to assess the torque to failure, insertion torque, axial pullout strength, and self-tapping performance of screws. No new bench testing was deemed required to assess the torsional properties, driving torque and axial pullout of the modified I.B.S.TM osteosynthesis screws. Therefore, the subject device was demonstrated to be as safe and effective as the above predicates.
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.
K131920, K052576, K082874, K160174, K944330
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
In2Bones SAS % Dr. Norman Estrin
May 10, 2017
Managing Partner Estrin Consulting Group LLC 3100 N. Leisure World Blvd., Apt. 121 Silver Spring, Maryland 20906
Re: K170594
Trade/Device Name: I.B.S. 110 osteosynthesis screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 18, 2017 Received: May 1, 2017
Dear Dr. Estrin:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
I.B.S.TM osteosynthesis screws
Indications for Use (Describe)
The I.B.S.TM compression and neutralization osteosynthesis screws are intended for:
-
The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs
-
Osteosynthesis requiring a mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is in a gray oval shape with a white curved line on the left side. The text "IN2BONES" is in white, with the "2" in orange.
510(k) Summary For In2Bones I.B.S.™ osteosynthesis screws device modification
| Sponsor identification | In2Bones SAS
28 chemin du Petit Bois
69130 Ecully – France
Phone: +33.4.72.29.26.26
Fax: +33.4.72.29.26.29 |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
registration number | 3010470577 |
| Date of preparation | May 7, 2017 |
| Contact person | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
3100 N. Leisure World Blvd.
Silver Spring, MD 20906
Phone: 240-994-9999
Email: estrin@yourFDAconsultant.com |
| Authorized Agent in
the United States
I.B.S.TM 2.0
Osteosynthesis Screw | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
3100 N. Leisure World Blvd.
Silver Spring, MD 20906
Phone: 240-994-9999
Email: estrin@yourFDAconsultant.com |
| Initial 510(k) number | K131920 |
| Proprietary Name | I.B.S.TM osteosynthesis screws |
| Common name | Bone fixation screw |
| Device classification
regulation | 21 CFR 888.3040: Smooth or threaded metallic bone fixation
screw or fastener
Class II |
| Device Product
Code and Panel | HWC: screw, fixation, bone
87 orthopedics |
| Device Description | The modified I.B.STM osteosynthesis screws are a range extension of the existing screw line cleared in K131920 I.B.STM osteosynthesis screw.
The modification made on the I.B.S.TM osteosynthesis screw are:
I.B.S.TM Osteosynthesis Compression Screw, diameter 6.5mm:
- Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references;
- Modification of the distal thread to a long distal thread for screws, with total length comprised between 60mm and 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Neutralization Screw, diameter 6.5mm:
- Range extension of the total screw length, with addition of lengths from 85mm to 120mm, and creation of dedicated references. I.B.S.TM Osteosynthesis Compression and Neutralization screw, diameter 2.5mm:
- Range extension of the total screw length, with addition of length 30mm, and creation of dedicated references. |
| Predicate Devices | Compression design: SBI, Autofix (K052576) Biomet Trauma, BioDrive Cannulated screw system (K082874) In2Bones, I.B.S.TM 2.0 Osteosynthesis screw (K160174) In2Bones, I.B.S.TM Osteosynthesis screw (K131920) Neutralization design: Acumed, Acutrak screws (K944330) Biomet Trauma, BioDrive Cannulated screw system (K082874) In2Bones, I.B.S.TM 2.0 Osteosynthesis screw (K160174) In2Bones, I.B.S.TM Osteosynthesis screw (K131920) |
| Indications for use: | The I.B.S.TM compression and neutralization osteosynthesis screws are intended for: - The fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs
- Osteosynthesis requiring a mono or bicortical compression
The size of the chosen screw should be adapted to the specific indications. |
| Comparison of
Technological
characteristics | The technological characteristics of the modified I.B.S.TM osteosynthesis screws are equivalent to the characteristics of predicate devices in terms of design, size range, raw material. All these implants have the following features: - Insertion into bone: The modified I.B.S.TM osteosynthesis screws and all predicate devices are intended for surgical implantation into bone for longer than 30 days.
- Design: Predicate devices have similar design as the modified I.B.S.TM osteosynthesis screws. They all are cannulated, self-tapping and self-drilling screws with either a compression or a neutralization design.
- Indications for use: Predicate devices have equivalent indications for use as the modified I.B.S.TM Osteosynthesis screws in terms of fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs. These non-identical indications are equivalent and do not impact the safety and effectiveness of the modified I.B.S.TM Osteosynthesis screws.
- Equivalent size range: Predicate devices have comparable size range of as the modified I.B.S.TM Osteosynthesis screws. The slightly difference of the predicates does not impact the safety and effectiveness of the modified I.B.S.TM Osteosynthesis screws.
The length discrepancies of the I.B.S.TM osteosynthesis screw predicate (K131920) in comparison to the modified I.B.S.TM Osteosynthesis screws 6.5mm diameter are the reason of this Special 510(k) submission and do not impact the safety and effectiveness of the modified I.B.S.TM Osteosynthesis screws 6.5mm diameter, as it is explained in the "Performance Testing" section. - Material: The modified I.B.S.TM osteosynthesis screws have identical raw material, when compared to the predicate: all are manufactured from Titanium alloy Ti6Al4V, according to ISO 5832-3 and ASTM F136 standards. |
| Substantial
Equivalence
Summary | As described above, the modified I.B.S.TM osteosynthesis screws
have similar technological characteristics when compared to the
predicate devices. |
| Summary
Performance
Data | The dimensional modifications between the unmodified I.B.S.TM
osteosynthesis Screws, K131920, and the modified I.B.S.TM
osteosynthesis Screws have been evaluated through dimensional
comparison with predicate devices and analysis of the impact on
mechanical behavior based on standard ASTM F543.
This standard describes methods to assess the torque to failure,
insertion torque, axial pullout strength, and self-tapping
performance of screws. No new bench testing was deemed
required to assess the torsional properties, driving torque and
axial pullout of the modified I.B.S.TM osteosynthesis screws.
Therefore, the subject device was demonstrated to be as safe
and effective as the above predicates |
| Pyrogen testing | The method used to make the determination that the device
meets pyrogen limit specification is the Limulus Amebocyte
Lysate (LAL) test in accordance with ANSI/AAMI
ST72:2011: Bacterial endotoxins – Test methods, routine
monitoring and alternative to batch testing. |
| CONCLUSION | Based on the evaluations and the results of the dimensional
comparison performed, the design and indications of the
modified I.B.S.TM osteosynthesis screws are substantially
equivalent to the predicate devices identified in the 510(k)
submission. No new materials or processes are used in the
development of this implant.
The modified I.B.S.TM osteosynthesis screws are acceptable
for the application. |
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