(109 days)
Not Found
No
The description focuses on the material, shape, and dimensions of a mechanical implant for fracture fixation. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device, a Femoral/Tibial Locking Nail, is used for "long bone fracture fixation," which is a treatment for injuries. Therefore, it serves a therapeutic purpose.
No
This device is an intramedullary nail used for long bone fracture fixation, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly describes physical, implantable medical devices (femoral and tibial locking nails made of titanium alloy) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the SP2 Femoral and Tibial Locking Nails are implants used for long bone fracture fixation. They are surgically inserted into the body to stabilize broken bones.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
The device is a surgical implant used for structural support and stabilization within the body, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The SP2 Femoral Locking Nail, like the predicate Stryker T2 Femoral Nail, is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws and end caps. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The SP2 Tibial Locking Nail, like the predicate Howmedica Osteonics Corporation Titan Tibial Nail K003018, is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws and end caps. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The SP2 Femoral Locking Nail is indicated for long bone fracture fixation specifically femoral fixation, which may include the following:
- . Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, including those with intra-articular extension .
- Ipsilateral femur fractures .
- Fractures proximal to a total knee arthroplasty .
- . Fractures distal to the hip joint
- . Nonunions and malunions
The SP2 Tibial Locking Nail is indicated for long bone fracture fixation specifically tibial fixation, which may include the following:
- Open or closed shaft fractures with a very proximal and very distal extent in . which locking screw fixation can be obtained
- . Pseudarthrosis
- Pathologic and impending pathologic fractures .
- Multi-fragment fractures ●
- . Segmental fractures
- Proximal or distal non-unions .
- Proximal or distal mal-unions
- Corrective osteotomies .
- Tumor resections
- Comminuted fractures with or without bone loss .
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Biomecanica SP2 Femoral Locking Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The Biomecanica SP2 Femoral Locking Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The Biomecanica SP2 Femoral Locking Nail is currently available in diameters ranging from 9 to 12 mm and lengths ranging from 180 to 460 mm.
The Biomecanica SP2 Tibial Locking Nail is a temporary fixation intramedullary nail designed for fracture fixation and stabilizations of the tibia. The intramedullary nails are available in diameter ranging from 9 to 11mm and lengths ranging from 200 to 440mm. Each of the nails is secured by a series of screws that pass through holds manufactured into the proximal and distal sections of each nail.
All components of the SP2 Femoral and Tibial Locking Nails are made of titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral, Tibial
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)
Not Found
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
K123745 (1/3)
Image /page/0/Picture/1 description: The image shows the word "BIOMECANICA" in a stylized font. Above the word, there are three curved lines that appear to be a design element. The word is in all caps and has a futuristic look. The image is in black and white.
MAR 2 5 2013
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
Proprietary Name
Date Prepared
Submitter
November 1, 2012
Biomecanica Indústria E Comérico de Productos Ortopédicos Ltda Rua Luiz Pengo, 145-1º Distrito Industrial, CEP: 17.203-970 Jau. Sao Paulo. Brazil Telephone: 55 (14) 2104-7983
SP2 Femoral Locking Nail, SP2 Tibial Locking Nail
Official Contact
Tara Conrad and Lilian Llull TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180 TEL- (305) 377-0077 FAX- (305) 377-0088
Common Name Intramedullary Nail Classification Name Intramedullary Fixation Rod Regulation Number & Product Codes HSB-21 CFR §888.3020 Proposed Regulatory Class Class II Predicate Device Identification T2 Femoral Nail K112059 Titan Tibial Nail K003018
Description of Proposed Device
The Biomecanica SP2 Femoral Locking Nail is a cylindrical, cannulated titanium alloy tube, slightly bowed to accommodate the shape of the femur. The Biomecanica SP2 Femoral Locking Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach. The Biomecanica SP2 Femoral Locking Nail is currently available in diameters ranging from 9 to 12 mm and lengths ranging from 180 to 460 mm.
The Biomecanica SP2 Tibial Locking Nail is a temporary fixation intramedullary nail designed for fracture fixation and stabilizations of the tibia. The intramedullary nails are available in diameter ranging from 9 to 11mm and lengths ranging from 200 to
1
Image /page/1/Picture/1 description: The image shows the word "BIOMECANICA" in a stylized font. Above the word, there is a graphic that looks like three curved lines, possibly representing motion or energy. The overall design appears to be a logo or branding element.
440mm. Each of the nails is secured by a series of screws that pass through holds manufactured into the proximal and distal sections of each nail.
All components of the SP2 Femoral and Tibial Locking Nails are made of titanium alloy.
Intended Use
The SP2 Femoral Locking Nail, like the predicate Stryker T2 Femoral Nail, is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws and end caps. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The SP2 Tibial Locking Nail, like the predicate Howmedica Osteonics Corporation Titan Tibial Nail K003018, is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws and end caps. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
Indications for Use
The SP2 Femoral Locking Nail is indicated for long bone fracture fixation specifically femoral fixation, which may include the following:
- . Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, including those with intra-articular extension .
- Ipsilateral femur fractures .
- Fractures proximal to a total knee arthroplasty .
- . Fractures distal to the hip joint
- . Nonunions and malunions
The SP2 Tibial Locking Nail is indicated for long bone fracture fixation specifically tibial fixation, which may include the following:
- Open or closed shaft fractures with a very proximal and very distal extent in . which locking screw fixation can be obtained
- . Pseudarthrosis
- Pathologic and impending pathologic fractures .
- Multi-fragment fractures ●
- . Segmental fractures
- Proximal or distal non-unions .
- Proximal or distal mal-unions
- Corrective osteotomies .
- Tumor resections
- Comminuted fractures with or without bone loss .
2
Image /page/2/Picture/1 description: The image shows the logo for "BIO MECANICA". Above the text is a graphic that looks like a stylized wing. The text is in a bold, sans-serif font. The logo is in black and white.
Substantial Equivalence
The information presented supports substantial equivalence of the Biomecanica SP2 Femoral Locking Nail and the T2 Femoral Nail manufactured by Stryker K112059. The information presented supports substantial equivalence of the Biomecanica SP2 Tibial Locking Nail and the Titan Tibial Nail by Howmedica Osteonics Corporation K003018. The proposed systems have the same intended uses, incorporates the same fundamental technology and is composed of the same material as the predicate devices. A tabular comparison between the SP2 Femoral and Tibial Locking Nails and cited predicates are included in this 510k.
Conclusion
This premarket notification is being submitted to request clearance for the SP2 Femoral and Tibial Locking Nails. The analysis on the SP2 Femoral and Tibial Locking Nails demonstrates substantial equivalence to the T2 Nail (K112059) and Titan Tibial Nail (K003018) predicates.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2013
Biomecanica Indústria E Comérico de Productos Orthopédicos Ltda % TechLink International Consulting Ms. Tara Conrad 18851 NE 29th Avenue, Suite 720 Aventura, Florida 33180
Re: K123745
Trade/Device Name: SP2 Femoral Locking Nail SP2, Tibial Locking Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 7, 2013 Received: February 11, 2013
Dear Ms. Conrad:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Tara Conrad
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Image /page/4/Picture/6 description: The image shows the name "Erin Dicith" in a stylized font. The letters "E", "r", "i", "n", "i", "t", and "h" are in a standard font. The letters "D", "c", and "i" are in a stylized font that resembles a circuit board.
Mark Melkerson Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Device Name: SP2 Femoral Locking Nail and SP2 Tibial Locking Nail
510(k) Number: (Pending) K123745
Indications for Use:
The SP2 Femoral Locking Nail is indicated for long bone fracture fixation specifically femoral fixation, which mav include the following:
- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, including those with intra-articular extension .
- Ipsilateral femur fractures .
- Fractures proximal to a total knee arthroplasty .
- Fractures distal to the hip ioint ●
- Nonunions and malunions .
The SP2 Tibial Locking Nail is indicated for long bone fracture fixation specifically tibial fixation, which may include the following:
- Open or closed shaft fractures with a very proximal and very distal . extent in which locking screw fixation can be obtained
- Pseudarthrosis .
- Pathologic and impending pathologic fractures .
- Multi-fragment fractures .
- Segmental fractures .
- . Proximal or distal non-unions
- . Corrective osteotomies
- Tumor resections �
- . Comminuted fractures with or without bone loss
Prescription Use ___ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use ________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Casev L. Hanley
Division of Orthopaedic Devices