Extended HA Half Pins

K210784 · Smith & Nephew, Inc. · JDW · Apr 2, 2021 · Orthopedic

Device Facts

• Record ID: K210784
• Device Name: Extended HA Half Pins
• Applicant: Smith & Nephew, Inc.
• Product Code: JDW · Orthopedic
• Decision Date: Apr 2, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Extended HA Half Pins are intended to be used with an external fixation system for fixation of fractures of long bones, joint fusions, and limb lengthening or deformity corrections that involve cutting of the bone and temporary stabilization for the indications listed below. 1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 2. Open and closed fracture fixation 3. Pseudarthrosis of long bones 4. Limb lengthening by distraction 5. Correction of bony or soft tissue deformities 6. Joint arthrodesis 7. Infected fractures 8. Nonunions

Device Story

Extended HA Half Pins are metallic bone fixation fasteners used with external fixation systems. They are design modifications of the predicate Jet-X HA Coated Half Pins, featuring an extended hydroxyapatite (HA) coating applied to the pin shank. The device is used by orthopedic surgeons in clinical settings to provide temporary stabilization for long bone fractures, joint fusions, and limb lengthening or deformity corrections. The pins are inserted into bone to provide mechanical fixation and stability during the healing or correction process. The extended HA coating is intended to improve bone-implant interface. The device is a passive mechanical implant; it does not involve software, algorithms, or electronic components.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing performed in accordance with FDA Guidance for Hydroxyapatite Coated Orthopedic Implants, with results included in the supplier Masterfile.

Technological Characteristics

Metallic bone fixation fastener with hydroxyapatite (HA) coating extended to the shank. Designed for use with external fixation systems. Performance characteristics and testing comply with FDA guidance for hydroxyapatite-coated orthopedic implants.

Indications for Use

Indicated for patients requiring external fixation for long bone fractures, joint fusions, limb lengthening, deformity correction, pseudarthrosis, infected fractures, or nonunions.

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

• Jet-X HA Coated Half Pins (K023921)
• Modification to Jet-X HA Coated Half Pins (K033289)

Submission Summary (Full Text)

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April 2, 2021

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Smith & Nephew, Inc. Thomas Fearnley Senior Regulatory Affairs Specialist 1450 E Brooks Rd Memphis, Tennessee 38116

## Re: K210784

Trade/Device Name: Extended HA Half Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JDW Dated: March 15, 2021 Received: March 16, 2021

### Dear Thomas Fearnley:

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 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ting Song, Ph.D., R.A.C. 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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# Indications for Use

510(k) Number (if known) K210784

Device Name Extended HA Half Pins

#### Indications for Use (Describe)

The Extended HA Half Pins are intended to be used with an external fixation system for fixation of fractures of long bones, joint fusions, and limb lengthening or deformity corrections that involve cutting of the bone and temporary stabilization for the indications listed below.

1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction

- 2. Open and closed fracture fixation
- 3. Pseudarthrosis of long bones
- 4. Limb lengthening by distraction
- 5. Correction of bony or soft tissue deformities

6. Joint arthrodesis

- 7. Infected fractures
- 8. Nonunions

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;"> ☑ </span> |
|----------------------------------------------|-------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;"> ☐ </span> |

|| | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# -We are smith&nephew

| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | March 13, 2021 |
| Name of Device: | Extended HA Half Pins |
| Common Name: | Pin, Fixation, Threaded |
| Device Classification Name and<br>Reference: | 21 CFR 888.3040 Smooth or threaded metallic bone fixation<br>fastener. |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | IDW |

#### Predicates

| Manufacturer | Description | Submission<br>Number | Clearance Date |
|----------------------|-----------------------------------------------|----------------------|------------------|
| Smith & Nephew, Inc. | Jet-X HA Coated Half Pins (primary predicate) | K023921 | February 5, 2003 |
| Smith & Nephew, Inc. | Modification to Jet-X HA Coated Half Pins | K033289 | January 13, 2004 |

#### Device Description

Subject of this premarket notification is the Extended HA Half Pins. The proposed devices are design modifications of the Jet-X HA Coated Half Pins to extend the HA coating to the shank of the Half Pins.

#### Indications for Use

The Extended HA Half Pins are intended to be used with an external fixation system for fixation of fractures of long bones, joint fusions, and limb lengthening or deformity corrections that involve cutting of the bone and temporary stabilization for the indications listed below.

- Fractures and disease which generally may result in joint contractures or loss of range of 1. motion and fractures requiring distraction
- Open and closed fracture fixation 2.
- Pseudarthrosis of long bones 3.
- 4. Limb lengthening by distraction
- Correction of bony or soft tissue deformities 5.
- 6. Joint arthrodesis

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- 7. Infected fractures
- 8. Nonunions

#### Technological Characteristics

Device comparisons described in this premarket notification demonstrated that the proposed devices are substantially equivalent to legally marketed predicates with respect to intended use, indications, and performance characteristics.

#### Summary of Pre-Clinical Testing

- Testing as required per FDA Guidance 510(K) Information Needed for Hydroxyapatite Coated . Orthopedic Implants has been completed and is included in the supplier Masterfile.
#### Conclusion

This Special 510(k) premarket notification is being submitted to request clearance for the Extended HA Half Pins. Based on similarities to the predicate Jet-X HA Coated Half Pins, the subject devices are substantially equivalent to the predicate devices.