(17 days)
Not Found
No
The document describes a physical orthopedic implant (half pins) and its intended use in external fixation systems. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The modifications described are related to the physical coating of the pins.
No
The device is an orthopedic implant for fracture fixation and limb correction, which falls under surgical and restorative devices, not therapeutic devices aimed at treating disease or illness directly.
No
The device description and intended use indicate it is an orthopedic implant for fixation and stabilization of bones, not for diagnosing conditions.
No
The device description clearly states the subject of the premarket notification is "Extended HA Half Pins," which are physical orthopedic implants, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a device used for surgical fixation of bones. It's a physical implant used within the body to stabilize fractures, perform limb lengthening, and correct deformities. This is a completely different function from testing samples outside the body.
The device described is an orthopedic implant, specifically a type of bone pin used in external fixation systems.
N/A
Intended Use / 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 motion and fractures requiring distraction
- Open and closed fracture fixation
- Pseudarthrosis of long bones
- Limb lengthening by distraction
- Correction of bony or soft tissue deformities
- Joint arthrodesis
- Infected fractures
- Nonunions
Product codes
JDW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
April 2, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (1-800-638-2041 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
2
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.
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
-
- Open and closed fracture fixation
-
- Pseudarthrosis of long bones
-
- Limb lengthening by distraction
-
- Correction of bony or soft tissue deformities
- Joint arthrodesis
-
- Infected fractures
-
- Nonunions
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
|| | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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."
3
-We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
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
Reference: | 21 CFR 888.3040 Smooth or threaded metallic bone fixation
fastener. |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | IDW |
Predicates
| Manufacturer | Description | Submission
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.
-
- Limb lengthening by distraction
- Correction of bony or soft tissue deformities 5.
-
- Joint arthrodesis
4
-
- Infected fractures
-
- 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.