OsteoCentric Integrated Hip Fastener System

K210247 · Osteocentric Technologies D.B.A. Osteocentric Trauma · JDO · Apr 30, 2021 · Orthopedic

Device Facts

• Record ID: K210247
• Device Name: OsteoCentric Integrated Hip Fastener System
• Applicant: Osteocentric Technologies D.B.A. Osteocentric Trauma
• Product Code: JDO · Orthopedic
• Decision Date: Apr 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OsteoCentric Integrated Hip Fastener System is intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.

Device Story

The OsteoCentric Integrated Hip Fastener System is a modular orthopedic implant system consisting of stainless steel plates and screws. It is used by orthopedic surgeons in a clinical/surgical setting for the internal fixation of femoral neck fractures. The device provides mechanical stabilization of bone fractures to facilitate healing. The surgeon selects appropriate plate and screw sizes based on patient anatomy. The system functions as a traditional bone fixation construct, providing structural support to the fractured femur. It does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

Bench testing only. Engineering analysis compared the subject device's plating/screw construct to predicates, evaluating material properties, moment of inertia, screw strength, and thread profiles to confirm mechanical equivalence.

Technological Characteristics

Modular bone fixation system; materials: Stainless Steel per ASTM F138; components: plates and screws of varying lengths/diameters; mechanical fixation principle; non-sterile; no software or electronic components.

Indications for Use

Indicated for patients requiring internal fixation of stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures where a stable medial buttress can be reconstructed.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Dynamic Hip Screw (K953607)
• Dynamic Hip Screw (K923613)
• Dynamic Hip Screw (K791619)
• Angled Blade Plate (K914546)
• Conquest FN (K193029)
• Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System (K150818)
• Trochanter Stabilization Plate for DHS (K000972)
• NCB Periprosthetic trochanter Plates and Screws (K120772)

Reference Devices

• SMV Scientific Cannulated Screws (K170021)

Submission Summary (Full Text)

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April 30, 2021

OsteoCentric Technologies d.b.a. OsteoCentric Trauma % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K210247

Trade/Device Name: OsteoCentric Integrated Hip Fastener System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDO, KTT Dated: January 28, 2021 Received: January 29, 2021

Dear Nathan Wright:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

# Christopher Ferreira -S

for

Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K210247

#### Device Name

0steoCentric Integrated Hip Fastener System

Indications for Use (Describe)

The OsteoCentric Integrated Hip Fastener System is intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div><span style="font-size: 20px;">☑</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> | <div style="display:flex; align-items:center;"><div><span style="font-size: 20px;">☐</span></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(K) SUMMARY

| Submitter's Name: | OsteoCentric Trauma |
|----------------------------|------------------------------------------------------------------------------------------|
| Submitter's Address: | 75 West 300 North Suite #150<br>Logan, UT 84321 |
| Submitter's Telephone: | 1-800-969-0639 |
| Contact Person: | Nathan Wright MS<br>Empirical Testing Corp.<br>719-351-0248<br>[e-mail] |
| Date Summary was Prepared: | January 28, 2021 |
| Trade or Proprietary Name: | OsteoCentric Integrated Hip Fastener System |
| Common or Usual Name: | Device, Fixation, Proximal Femoral, Implant |
| Classification: | Class II per 21 CFR §888.3030 |
| Regulation Name: | Single/Multiple Component Metallic Bone Fixation Appliances<br>And Accessories |
| Product Code: | JDO, KTT |
| Classification Panel: | Orthopedic |

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The OsteoCentric Integrated Hip Fastener System is intended for use in internal fixation of femoral neck fractures. The OsteoCentric Integrated Hip Fastem consist of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided non-sterile. All implantable devices are manufactured from Stainless Steel per ASTM F138.

## INDICATIONS FOR USE

The OsteoCentric Integrated Hip Fastemer System is intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.

## TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

- . Indications for Use
- . Materials of Manufacture

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| 510k Number | Trade or Proprietary<br>or Model Name | Manufacturer | Device Category |
|------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------|-----------------|
| K953607 | Dynamic Hip Screw | Synthes (USA) | Primary |
| K923613, K791619 | Dynamic Hip Screw | Synthes (USA) | Additional |
| K914546 | Angled Blade Plate | Synthes (USA) | Additional |
| K193029 | Conquest FN | Smith & Nephew, Inc. | Additional |
| K150818 | Versa-Fx Femoral<br>Fixation System, Versa-<br>Fx II Femoral Fixation<br>System, Free-Lock<br>Femoral Fixation System | Zimmer, Inc. | Additional |
| K000972 | Trochanter Stabilization<br>Plate for DHS® | Synthes (USA) | Additional |
| K120772 | NCB Periprosthetic<br>trochanter Plates and<br>Screws | Zimmer GMBH | Additional |
| K170021 | SMV Scientific<br>Cannulated Screws | SMV Scientific | Reference |

# PERFORMANCE DATA

An engineering analysis was performed to compare the subject plating construct to the predicates. Similar to the predicates, the subject plating/screw construct is also a modular stainless steel bone fixation system with similar interlocking features, plate angulation, plate lengths, plate widths, plate thicknesses, screw sizes and screw lengths. Plate strength and stiffness was compared by evaluating the material properties and moment of inertia at worst-case locations. Screw strength was evaluated and compared to the predicates using the material properties, screw types and sizes. Screw fixation was evaluated and compared to predicates using information about the thread profile. The results of the engineering analysis confirmed that the strength, stiffness and fixation of the OsteoCentric Integrated Hip Fastemer System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

# CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the OsteoCentric Integrated Hip Fastener System is substantially equivalent to the predicate device.