OsteoMed ExtremiFix Mid and Large Screw System

K163303 · Osteomed, LLC · HWC · Apr 4, 2017 · Orthopedic

Device Facts

• Record ID: K163303
• Device Name: OsteoMed ExtremiFix Mid and Large Screw System
• Applicant: Osteomed, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Apr 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Rigid bone fixation system comprising cannulated and solid screws, washers, and associated surgical instruments. Screws available in various lengths and diameters to accommodate patient anatomy. Input: surgical site anatomy; Transformation: mechanical fixation via screw insertion into bone; Output: stabilized bone segments. Used in healthcare facilities by clinicians for orthopedic procedures. Benefits: provides mechanical stability to facilitate bone healing in reconstruction, osteotomy, arthrodesis, and fracture repair. System features dual-lead technology, self-drilling/self-tapping capabilities, and reverse cutting flutes. Implants are single-use; instruments are provided in modules for surgical customization.

Clinical Evidence

No clinical data performed. Substantial equivalence supported by bench testing including self-tapping force, safety factor (failure torque/insertion torque), pullout force, torsional strength, bending strength, sterilization validation, and endotoxin testing. Biocompatibility testing conducted per ISO 10993-1.

Technological Characteristics

Material: Titanium Alloy Ti 6Al-4V (ASTM F136). Design: Cannulated and solid screws, headed and headless, hexalobe head type. Features: Dual-lead technology, self-drilling, self-tapping, reverse cutting flutes. Dimensions: 20-180mm length, 4.5-7.0mm diameter. Energy: None (mechanical). Sterilization: Provided sterile (implants) or via sterilization tray. Connectivity: None.

Indications for Use

Indicated for bone reconstruction, osteotomy, arthrodesis, and fracture fixation of foot, ankle, and long bones (upper and lower extremity) in patients requiring rigid bone fixation.

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

• 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)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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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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)

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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: | [e-mail] |

| Contact: | Kathryn Jayne |
|----------|---------------------|
| Phone: | 972-677-4766 |
| Fax: | 800-390-2620 |
| Email: | [e-mail] |

Alternate Contact: Phone: Email:

Alicia Hemphill 972-677-4786 [e-mail]

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".

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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<br>Name | Subject Device | Primary Predicate | Secondary Predicate | Reference Predicate | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | OsteoMed ExtremiFix Mid<br>and Large Screw System<br>Image: OsteoMed ExtremiFix Mid and Large Screw System | OsteoMed Headless<br>Cannulated Screw<br>System<br>Image: OsteoMed Headless Cannulated Screw System | OsteoMed Cannulated<br>Screw System<br>Image: OsteoMed Cannulated Screw System | Synthes Sterile 4.5mm<br>Cannulated Screws<br>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<br>/ Intended Use | Fracture fixation,<br>reconstruction, osteotomy,<br>and arthrodesis procedures<br>of foot, ankle, and long<br>bones (upper and lower<br>extremity). | Bone reconstruction,<br>osteotomy, arthrodesis,<br>joint fusion, fracture<br>repair, and fracture<br>fixation of bones<br>appropriate for the size of<br>the device. Screws are<br>intended for single use<br>only. | Bone Fixation of hand<br>and foot following<br>trauma or osteotomy.<br>Screws and washers are<br>intended for single use<br>only. | Fracture fixation of long<br>bones and long bone<br>fragments. | |
| Material | Titanium Alloy - Ti 6Al-4V<br>(ASTM F136) | Titanium Alloy - Ti 6Al-<br>4V<br>(ASTM F136) | Titanium Alloy - Ti 6Al-<br>4V<br>(ASTM F136) | Titanium Alloy - Ti<br>6Al-4V<br>and<br>Stainless Steel | |
| Technology | Screws to fixate Bone | Screws to fixate Bone | Screws to Fixate Bone | Screws to Fixate Bone | |
| Operating<br>Principles | Rigid fixation | Rigid fixation | Rigid fixation | Rigid fixation | |
| Insertion Material | Bone | Bone | Bone | Bone | |
| Screw Length<br>(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<br>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<br>Name | OsteoMed ExtremiFix Mid<br>and Large Screw System | OsteoMed Headless<br>Cannulated Screw<br>System | OsteoMed Cannulated<br>Screw System | Synthes Sterile 4.5mm<br>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<br>HD Cannulated ST, LT,&<br>FT<br>Headed Solid ST | Headless<br>Cannulated | Headed<br>Cannulated | Headed<br>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<br>Flutes | Yes | No | No | Yes |
| | Availability | Yes | No | Yes | Yes |
| Washers | Part<br>Numbers | 316-0325<br>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<br>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<br>Preparation Instruments | Single Use and Re-usable<br>Preparation Instruments | Single Use and Re-usable<br>Preparation Instruments | Single Use and Re-<br>usable Preparation<br>Instruments |
| | Instrumentation<br>Materials | Stainless Steel,<br>Anodized Aluminum,<br>Medical grade polymer | Stainless Steel,<br>Anodized Aluminum,<br>Medical grade plastic | Stainless Steel,<br>Anodized Aluminum,<br>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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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)