(133 days)
No
The 510(k) summary describes a mechanical fixation system (screws, washers, instruments) and focuses on material properties and mechanical performance testing. There is no mention of AI, ML, image processing, or data-driven algorithms.
No
Explanation: This device is for bone reconstruction and fracture fixation, not for treating or preventing a disease or condition. While it aids in recovery, its primary function is mechanical support.
No
This device is a surgical fixation system consisting of screws and instruments used for bone reconstruction, osteotomy, arthrodesis, and fracture fixation. It is explicitly indicated for treatment and repair, not for diagnosing conditions.
No
The device description clearly states it is a rigid fixation system consisting of screws, washers, drills, and guide wires, which are all 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 (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The OsteoMed ExtremiFix Mid & Large Screw System is a surgical implant used for bone reconstruction, osteotomy, arthrodesis, and fracture fixation. It is physically implanted into the body to provide structural support and stability to bones.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the body. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the OsteoMed ExtremiFix Mid & Large Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OsteoMed ExtremiFix Mid & Large Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, and fracture fixation of foot, ankle, and long bones (upper and lower extremity). The screws are intended for single use only. The system drills and guide wires are single use instruments.
Product codes
HWC, HTN
Device Description
The OsteoMed ExtremiFix Mid & Large Screw System is a rigid fixation system consisting of screws in both cannulated and solid versions, all of which are available in various overall and distal thread lengths to accommodate specific patient anatomies. The headed and headless compression screws are made of biocompatible Ti 6-Al 4-V Titanium Alloy. Longer sizes of the single-use only implants are provided individually sterile packed, while the majority of screws and all instruments are provided in modules to allow for customization specific to the surgical indication. The system includes washers for use with 4.5mm, 5.5mm, 6.5mm and 7.0mm headed screws. The washers are made of biocompatible Titanium Alloy. The OsteoMed ExtremiFix Mid & Large Screw System is sterilized in a sterilization tray which is available from OsteoMed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, and long bones (upper and lower extremity)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility/hospital for use by a clinician.
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)
Verification testing was conducted to ensure the subject screws performed equal or better compared to the predicate devices. The subject screws were also tested against the Synthes predicate reference device to ensure the design features met the required mechanical strength criteria for their intended use. The screws with the dual lead technology underwent verification evaluation to ensure the new design features met the mechanical strength criteria for the intended use. The screws were compared to their respective predicate.
Performance equivalence was shown through the verification comparison to the predicate devices.
Clinical Testing is not required to support substantial equivalence.
Biocompatibility: The biocompatibility evaluation for the device was conducted in accordance with the FDA Guidance Document, issued on June 16, 2016, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" – Guidance for Industry and Food and Drug Administration Staff.
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Sub-chronic toxicity
- Genotoxicity
- o Implantation
- o Pyrogen testing
Bench Testing:
- o Self-Tapping Force
- Safety Factor (Failure Torque / Insertion Torque)
- Pullout Force
- Torsional Strength (Solid Screws Only)
- Bending Strength
- Sterilization Validation
- Endotoxin Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OsteoMed Headless Cannulated Screw (K063298), OsteoMed Cannulated Screw System (K151021), Synthes Sterile 4.5 mm Cannulated Screws (K963172), Smith & Nephew Richards, Inc. Screw (K951389), OsteoMed Super Screw System (K954330)
Reference Device(s)
Synthes Sterile 4.5mm Cannulated Screws (K963172)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures connected by flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2017
OsteoMed LLC Kathryn Jayne Senior Specialist, Regulatory Affairs 3885 Arapaho Rd Addison, Texas 75001
Re: K163303
Trade/Device Name: OsteoMed ExtremiFix Mid And Large Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: March 8, 2017 Received: March 10, 2017
Dear Ms. Kathryn Jayne:
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 (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.
1
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
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163303
Device Name
OsteoMed ExtremiFix Mid & Large Screw System
Indications for Use (Describe)
indications of Ose (Deschib)
The OsteoMed ExtremiFix Mid & Large Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, THE Ostoonied Extremit In this co, and long bones (upper and lower extremity). The screws are intended for single use only. The system drills and guide wires are single use instruments.
Type of Use (Select one or both, as applicable)
2 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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the i i a review instructions, search existing data sources, gather and maintain the data needed and complete time to review the collection. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image shows the OsteoMed logo, which is a blue and gray oval shape with the word "OsteoMed" in blue letters. The logo has a registered trademark symbol. Below the logo is the text "K163303".
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510(k) SUMMARY
I. SUBMITTER
OsteoMed 3885 Arapaho Rd. Addison, TX 75001
| Phone: | 972-677-4766 |
|---|---|
| Fax: | 800-390-2620 |
| Email: | kjayne@osteomed.com |
| Contact: | Kathryn Jayne |
|---|---|
| Phone: | 972-677-4766 |
| Fax: | 800-390-2620 |
| Email: | kjayne@osteomed.com |
Alternate Contact: Phone: Email:
Alicia Hemphill 972-677-4786 ahemphill@osteomed.com
Date Prepared:
March 28, 2017
II. DEVICE
| Name of the Device: | OsteoMed ExtremiFix Mid and Large Screw System |
|---|---|
| Common or Usual Name: | Bone Fixation Screw System |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation: | 888.3040 |
| Regulatory Class: | II |
| Product Code: | HWC, HTN |
III. PREDICATE DEVICE
| Primary Predicate: | OsteoMed Headless Cannulated Screw (K063298) |
|---|---|
| Additional Predicate: | OsteoMed Cannulated Screw System (K151021) |
| Additional Predicate: | Synthes Sterile 4.5 mm Cannulated Screws (K963172) |
| Additional Predicate: | Smith & Nephew Richards, Inc. Screw (K951389) |
| Additional Predicate: | OsteoMed Super Screw System (K954330) |
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Image /page/4/Picture/1 description: The image shows the OsteoMed logo, which is a blue and gray design. The word "OsteoMed" is written in blue, with a gray swoosh underneath. Below the logo, the text "K163303" is printed in a simple font.
DEVICE DESCRIPTION IV.
The OsteoMed ExtremiFix Mid & Large Screw System is a rigid fixation system consisting of screws in both cannulated and solid versions, all of which are available in various overall and distal thread lengths to accommodate specific patient anatomies. The headed and headless compression screws are made of biocompatible Ti 6-Al 4-V Titanium Alloy. Longer sizes of the single-use only implants are provided individually sterile packed, while the majority of screws and all instruments are provided in modules to allow for customization specific to the surgical indication. The system includes washers for use with 4.5mm, 5.5mm, 6.5mm and 7.0mm headed screws. The washers are made of biocompatible Titanium Alloy. The OsteoMed ExtremiFix Mid & Large Screw System is sterilized in a sterilization tray which is available from OsteoMed.
The subject device is intended for use in a healthcare facility/hospital for use by a clinician. It is a prescription device.
V. INDICATIONS FOR USE
The OSTEOMED ExtremiFix Mid & Large Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, and fracture fixation of foot, ankle, and long bones (upper and lower extremity). The screws are intended for single use only. The system drills and guide wires are single use instruments.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
Performance Characteristics & Testing & Clinical
Verification testing was conducted to ensure the subject screws performed equal or better compared to the predicate devices. The subject screws were also tested against the Synthes predicate reference device to ensure the design features met the required mechanical strength criteria for their intended use. The screws with the dual lead technology underwent verification evaluation to ensure the new design features met the mechanical strength criteria for the intended use. The screws were compared to their respective predicate.
Performance equivalence was shown through the verification comparison to the predicate devices.
Clinical Testing is not required to support substantial equivalence.
Substantial Equivalence
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Image /page/5/Picture/1 description: The image shows the Osteomed logo, which is a stylized oval shape with the word "OSTEOMED" in bold, sans-serif font. The top half of the oval is blue, while the bottom half is gray. Below the logo is the text "K163303".
Pg.3/6
The basis of substantial equivalence for this device, the OsteoMed ExtremiFix Mid and Large Screw System, is based on similarities in indications for use, intended use, material, function, performance, design, technology, sterilization, and operational principles to the OsteoMed predicates and Synthes predicate. Performance comparisons were performed which verified that the new screw system met required mechanical strength criteria for their intended use compared to the legally marketed predicate devices listed in this summary. OsteoMed has shown that the non-clinical tests demonstrate that the devices are as safe and as effective as the predicate devices.
| System/Device
| Name | Subject Device | Primary Predicate | Secondary Predicate | Reference Predicate | |
|---|---|---|---|---|---|
| OsteoMed ExtremiFix Mid | |||||
| and Large Screw System | |||||
| Image: OsteoMed ExtremiFix Mid and Large Screw System | OsteoMed Headless | ||||
| Cannulated Screw | |||||
| System | |||||
| Image: OsteoMed Headless Cannulated Screw System | OsteoMed Cannulated | ||||
| Screw System | |||||
| Image: OsteoMed Cannulated Screw System | Synthes Sterile 4.5mm | ||||
| Cannulated Screws | |||||
| Image: Synthes Sterile 4.5mm Cannulated Screws | |||||
| 510(k) Number | Pending | K063298 | K151021 | K963172 | |
| Regulation No. | 888.3040 | 888.3040 | 888.3040 | 888.3040 | |
| Product Code | HWC, HTN | HWC | HWC | HWC | |
| Device Class | II | II | II | II | |
| Regulatory Panel | Orthopedic | Orthopedic | Orthopedic | Orthopedic | |
| Indication for Use | |||||
| / Intended Use | Fracture fixation, | ||||
| reconstruction, osteotomy, | |||||
| and arthrodesis procedures | |||||
| of foot, ankle, and long | |||||
| bones (upper and lower | |||||
| extremity). | Bone reconstruction, | ||||
| osteotomy, arthrodesis, | |||||
| joint fusion, fracture | |||||
| repair, and fracture | |||||
| fixation of bones | |||||
| appropriate for the size of | |||||
| the device. Screws are | |||||
| intended for single use | |||||
| only. | Bone Fixation of hand | ||||
| and foot following | |||||
| trauma or osteotomy. | |||||
| Screws and washers are | |||||
| intended for single use | |||||
| only. | Fracture fixation of long | ||||
| bones and long bone | |||||
| fragments. | |||||
| Material | Titanium Alloy - Ti 6Al-4V | ||||
| (ASTM F136) | Titanium Alloy - Ti 6Al- | ||||
| 4V | |||||
| (ASTM F136) | Titanium Alloy - Ti 6Al- | ||||
| 4V | |||||
| (ASTM F136) | Titanium Alloy - Ti | ||||
| 6Al-4V | |||||
| and | |||||
| Stainless Steel | |||||
| Technology | Screws to fixate Bone | Screws to fixate Bone | Screws to Fixate Bone | Screws to Fixate Bone | |
| Operating | |||||
| Principles | Rigid fixation | Rigid fixation | Rigid fixation | Rigid fixation | |
| Insertion Material | Bone | Bone | Bone | Bone | |
| Screw Length | |||||
| (mm) | 20mm - 180mm | 10mm -120mm | 10mm -140mm | 20mm - 80mm | |
| Screw Diameter | 4.5mm - 7.0mm | 2.0mm - 6.5mm | 3.0mm -8.0mm | 4.0 mm | |
| Head Type | Hexalobe | Trilobe | Cruciform | ||
| Hex | Hex | ||||
| Headless (HL) | Yes | Yes | No | No | |
| Headed (HD) | Yes | No | Yes | Yes | |
| Cannulated | Yes | Yes | Yes | Yes | |
| Solid | Yes | No | No | No | |
| Short Thread (ST) | Yes | Yes | Yes | Yes | |
| Subject Device | Primary Predicate | Secondary Predicate | Reference Predicate | ||
| System/Device | |||||
| Name | OsteoMed ExtremiFix Mid | ||||
| and Large Screw System | OsteoMed Headless | ||||
| Cannulated Screw | |||||
| System | OsteoMed Cannulated | ||||
| Screw System | Synthes Sterile 4.5mm | ||||
| Cannulated Screws | |||||
| 510(k) Number | Pending | K063298 | K151021 | K963172 | |
| Long Thread (LT) | Yes | Yes | No | No | |
| Full Thread (FT) | Yes | No | No | Yes | |
| Screw Type | HL Cannulated ST & LT | ||||
| HD Cannulated ST, LT,& | |||||
| FT | |||||
| Headed Solid ST | Headless | ||||
| Cannulated | Headed | ||||
| Cannulated | Headed | ||||
| Cannulated | |||||
| Double-Lead | Yes | No | No | No | |
| Low Profile Heads | Yes | Yes | Yes | TBD | |
| Self-Drilling | Yes | Yes | Yes | Yes | |
| Self-Tapping | Yes | Yes | Yes | Yes | |
| Lag | Yes | Yes | Yes | Yes | |
| Reverse Cutting | |||||
| Flutes | Yes | No | No | Yes | |
| Availability | Yes | No | Yes | Yes | |
| Washers | Part | ||||
| Numbers | 316-0325 | ||||
| 316-0326 | N/A | 316-0225 | 419.91 | ||
| Screw Size | 4.5 - 5.5 mm | N/A | 3.0 mm | 4.5mm | |
| Thickness | 1.0 mm | N/A | 1.0 mm | N/A | |
| Outer | |||||
| Diameter | 10.0 -11.0 mm | N/A | 12.4 mm | 10 mm | |
| Material | Titanium Alloy | N/A | Titanium Alloy | CPTi | |
| Instrumentation | Single Use and Re-usable | ||||
| Preparation Instruments | Single Use and Re-usable | ||||
| Preparation Instruments | Single Use and Re-usable | ||||
| Preparation Instruments | Single Use and Re- | ||||
| usable Preparation | |||||
| Instruments | |||||
| Instrumentation | |||||
| Materials | Stainless Steel, | ||||
| Anodized Aluminum, | |||||
| Medical grade polymer | Stainless Steel, | ||||
| Anodized Aluminum, | |||||
| Medical grade plastic | Stainless Steel, | ||||
| Anodized Aluminum, | |||||
| Medical grade polymer | Stainless Steel |
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Image /page/6/Picture/1 description: The image shows the Osteomed logo, which is a blue and gray oval shape with the word "OSTEOMED" in blue letters inside. The logo is placed above the text "K163303", which is likely a product or reference number. The logo is clean and professional, suggesting a company in the medical or healthcare industry.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
The biocompatibility evaluation for the device was conducted in accordance with the FDA Guidance Document, issued on June 16, 2016, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1:
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Image /page/7/Picture/1 description: The image shows the logo for Osteomed, a medical device company. The logo is in blue and gray, and the text "OSTEOMED" is in bold, blue letters. Below the logo is the text "K163303".
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Evaluation and testing within a risk management process" – Guidance for Industry and Food and Drug Administration Staff.
- Cytotoxicity ●
- Sensitization ●
- Irritation
- Systemic toxicity ●
- Sub-chronic toxicity ●
- Genotoxicity ●
- o Implantation
- o Pyrogen testing
The instruments are considered tissue contacting for a duration of less than 24 hours while the implants are considered permanent implants. The Titanium alloy implant material conforms to ASTM F-136 for chemical composition.
Electrical Safety and Electromagnetic Compatibility (EMC)
The OsteoMed ExtremiFix Mid & Large Screw System is not an active device; therefore, Electrical Safety and Electromagnetic Compatibility (EMC) testing is not applicable.
Software Verification and Validation Testing
The OsteoMed ExtremiFix Mid & Large Screw System does not contain software; therefore, Software Verification and Validation Testing is not applicable.
Bench Testing
The following bench evaluations were conducted:
- o Self-Tapping Force
- Safety Factor (Failure Torque / Insertion Torque) ●
- Pullout Force ●
- Torsional Strength (Solid Screws Only)
- Bending Strength
- Sterilization Validation ●
- Endotoxin Testing ●
Animal Study
No animal studies were performed to demonstrate safety and efficacy.
Clinical Studies
No clinical studies were performed to demonstrate safety and efficacy.
VIII. CONCLUSIONS
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Image /page/8/Picture/1 description: The image shows the Osteomed logo, which is a blue and gray oval shape with the word "OSTEOMED" in blue letters. Below the logo is the text "K163303". The logo is simple and modern, and the text is clear and easy to read. The image is likely used for branding or identification purposes.
The basis of substantial equivalence for the proposed device is based on similarities in indications for use, material, function, performance, design, technology, sterilizations, and operating principles. The non-clinical data support the substantial equivalence and demonstrates that the device should perform as intended in the specified use conditions.
(End of Summary)