(83 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is an intramedullary nail system used for the fixation of various long bone fractures and nonunions, which is a therapeutic purpose.
No
The device description and intended use clearly state that the China Nails are used for treating and reconstructing bone fractures, not for diagnosing them. It is an orthopedic implant.
No
The device description explicitly lists and describes physical implant components (intramedullary nails, screws) made of titanium alloy, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description clearly states that the China Nails are implants made of titanium alloy and are used for fixing bone fractures and other orthopedic issues. This is a surgical implant used within the body.
The information provided describes a device used for surgical intervention and bone repair, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The China Nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. China Nails are for single use only.
Product codes (comma separated list FDA assigned to the subject device)
JDS
Device Description
Subject devices of this submission are China Nails and Accessories. The implant components included in the system are described in the following table.
| China Nails and Accessories | Diameter | Length |
|---|---|---|
| Intramedullary Nails | ||
| Universal Nails | 9, 10, 11 mm | 17 cm |
| Right and Left Hand Nails | 9, 10, 11 mm | 26 - 46 cm |
| Screws | ||
| Lag Screws | 8.6 mm | 70 - 125 mm |
| Compression Screws | 6.2 mm | 65 - 120 mm |
| Nail Cap Set Screws | 6.6 mm | 0, 5, 10 mm |
| Distal Locking Screw | 4.5 mm | 20 - 65 mm |
| 5.0 mm | 20 - 110 mm | |
| The implants are manufactured from titanium alloy (Ti-6Al-4V). |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bone, femoral shaft/neck, intertrochanteric, intracapsular
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)
Mechanical testing was conducted and the results were compared to testing conducted on predicate devices. Fatigue testing and a wear evaluation confirmed that the China Nails and Accessories are equivalent to the predicate devices and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
123948
Smith & Nephew, Inc. Summary of Safety and Effectiveness China Nails and Accessories
MAR 1 4 2013
Contact Person and Address:
Date of Summary: December 19, 2012
Jason Sells Group Manager, Regulatory Affairs Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova. TN 38016 (901) 399-5520
Name of Device: China Nails and Accessories Common Name: Intramedullary nail and accessories Device Classification Name and Reference: 21CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories
Device Class: II Panel Code: Orthopaedics/87 JDS
Predicate Devices:
Smith & Nephew TRIGEN InterTAN (K040212) Smith & Nephew SURESHOT TAN and Accessories (K092748) Smith & Nephew TRIGEN Low Profile Bone Screws (K111025)
Device Description:
Subject devices of this submission are China Nails and Accessories. The implant components included in the system are described in the following table.
| China Nails and Accessories | Diameter | Length |
|---|---|---|
| Intramedullary Nails | ||
| Universal Nails | 9, 10, 11 mm | 17 cm |
| Right and Left Hand Nails | 9, 10, 11 mm | 26 - 46 cm |
| Screws | ||
| Lag Screws | 8.6 mm | 70 - 125 mm |
| Compression Screws | 6.2 mm | 65 - 120 mm |
| Nail Cap Set Screws | 6.6 mm | 0, 5, 10 mm |
| Distal Locking Screw | 4.5 mm | 20 - 65 mm |
| 5.0 mm | 20 - 110 mm |
The implants are manufactured from titanium alloy (Ti-6Al-4V).
Intended Use:
The China Nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. China Nails are for single use only.
Substantial Equivalence Information:
The overall design, materials, and indications for the China Nails and Accessories are substantially equivalent to the commercially available predicate devices. China Nails and Accessories are similar to predicate devices as follows.
1
Smith & Nephew, Inc. Summary of Safety and Effectiveness China Nails and Accessories
- The indications for the China Nails and Accessories are the same as for the . TRIGEN InterTAN.
- All three systems (China Nail, TRIGEN InterTAN and the SURESHOT TAN Nail) . include an option to use the combination lag screw/compression screw design.
- All three systems (China Nail, TRIGEN InterTAN and the SURESHOT TAN Nail) . are manufactured from titanium alloy.
- The distal screw holes for the China Nails and the SURESHOT TAN Nail . Systems incorporate internal threads to aid in screw stability.
- The Locking Screw have the same design as the TRIGEN Low Profile Bone . Screw cleared in K111025. The only difference is the surface anodization. The TRIGEN Low Profile Bone Screws are anodized while the China Nails Locking Screws are non-anodized.
Based on the comparisons, it is determined that the China Nails and Accessories are substantially equivalent to the predicate devices.
Technological Characteristics
Mechanical testing was conducted and the results were compared to testing conducted on predicate devices. Fatigue testing and a wear evaluation confirmed that the China Nails and Accessories are equivalent to the predicate devices and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices
Conclusion
Based on the indications for use, similarities of designs, and the performance testing, it is determined that the China Nails and Accessories are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002
March 14, 2013
Smith & Nephew, Incorporated % Mr. Jason Sells Group Manager, Regulatory Affairs 1450 Brooks Road Memphis, Tennessee 38116
Re: K123948
Trade/Device Name: China Nails and Accessories Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: Class II Product Code: JDS Dated: December 19, 2012 Received: December 21, 2012
Dear Mr. Sells:
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. Drue, 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
3
Page 2 - Mr. Jason Sells
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Image /page/3/Picture/6 description: The image shows the name "Erin Keith" in a stylized font. The first name, "Erin," is written in a simple, bold font. The last name, "Keith," is written in a more decorative font, with the letters outlined and filled with patterns.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K123948
Device Name: China Nails and Accessories
Indications for Use:
The China Nails are indicated for simple long bone fractures; severely comminuted, rnic Unina Nallo and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, multiple fractures, prophylaole hating bone lengthening and shortening; subtrochanteric following turnor roodotion and gatt/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. China Nail is for single use only.
Over-The-Counter Use AND/OR
Prescription Use (Optional Format 1-2-96) (Part 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey Hanley, Ph.D.
Division of Orthopaedic Devices
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