(150 days)
Not Found
No
The summary describes a purely mechanical implant made of biodegradable material for tissue fixation, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
No
The device is an implant for fixation of tissue or bone, used in various orthopedic repairs and reconstructions, and is not designed to treat a disease or medical condition.
No
The device description indicates it is an implantable device used for tissue fixation, such as ligaments or tendons to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an implant manufactured from physical materials (PLDLA combined with biphasic calcium phosphate), indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of tissue (ligament, tendon, bone) during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is described as an "implant" manufactured from biodegradable material, designed to be placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is an implant used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The Arthrex BioComposite TransFix is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Fixation with the BioComposite TransFix is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically;
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Knee: Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Hand/Wrist: Ligament Scapholunate Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
Product codes (comma separated list FDA assigned to the subject device)
HWC, MAI
Device Description
The Arthrex BioComposite TransFix is very similar to the predicate devices in diameter, and length. The difference lies in the biodegradable material used to manufacture the new model and the addition of a longer device. The implants will be manufactured from PLDLA combined with biphasic calcium phosphate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, shoulder, elbow, ankle, foot, and hand/wrist
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)
The submitted mechanical testing data demonstrated that the degradation shear strength, through 16 weeks, of the proposed devices meets or exceeds the shear strength of the predicate device.
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.
K062466 (Arthrex Interference Screw)
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
Arthrex SPECIAL 510(k): Arthrex BioComposite TransFix
1 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | December 14, 2011 | |
|---|---|---|
| Purpose of Submission | To obtain clearance of new Arthrex BioComposite TransFix devices. | |
| Manufacturer/Distributor | ||
| /Sponsor | Arthrex, Inc. | |
| 1370 Creekside Boulevard | ||
| Naples, FL 34108-1945 USA | ||
| 510(k) Contact | Courtney Smith | |
| Manager, Regulatory Affairs | ||
| Arthrex, Inc. | ||
| 1370 Creekside Boulevard | ||
| Naples, FL 34108-1945 USA | ||
| Telephone: 239/643.5553, ext. 1270 | ||
| Fax: 239/598.5508 | ||
| Email: courtney.smith@arthrex.com | ||
| Trade Name | BioComposite TransFix | |
| Common Name | Pin, Fixation, Bone | |
| Product Code - | ||
| Classification Name | HWC - Screw, fixation, bone | |
| MAI - Fastener, fixation, biodegradable | ||
| 21 CFR 888.3030: Single/multiple component metallic bone | ||
| fixation appliances and accessories. | ||
| Predicate Devices | K062466 (Arthrex Interference Screw): Arthrex Bio-TransFix | |
| Device Description and | ||
| Intended Use | The Arthrex BioComposite TransFix is very similar to the predicate devices in diameter, and length. The difference lies in the biodegradable material used to manufacture the new model and the addition of a longer device. The implants will be manufactured from PLDLA combined with biphasic calcium phosphate. |
The Arthrex BioComposite TransFix is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Fixation with the BioComposite TransFix is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles | |
| | | Tendon Repair, Hallux Valgus Reconstruction,
Midfoot Reconstruction, Metatarsal Ligament
Repair, Flexor Hallucis Longus for Achilles Tendon
reconstruction, tendon transfers in the foot and ankle |
| | Knee: | Anterior Cruciate Ligament Repair, Medial
Collateral Ligament Repair, Lateral Collateral
Ligament Repair, Patellar Tendon Repair, Posterior
Oblique Ligament Repair, Illiotibial Band Tenodesis |
| | Elbow: | Biceps Tendon Reattachment, Ulnar or Radial
Collateral Ligament Reconstruction |
| | Hand/Wrist: | Scapholunate Ligament Reconstruction, Ulnar
Collateral Ligament Reconstruction, Radial
Collateral Ligament Reconstruction,
Carpometacarpal joint arthroplasty (basal thumb joint
arthroplasty), Carpal Ligament Reconstructions and
repairs, tendon transfer in the hand/ wrist |
| Substantial Equivalence
Summary | The Arthrex BioComposite TransFix is substantially equivalent
to the Arthrex Bio-TransFix predicates, in which the basic
features and intended uses are the same. Any differences
between the BioComposite TransFix and the predicates are
considered minor and do not raise questions concerning safety
and effectiveness. | |
| | The proposed devices are composed of PLDLA/biphasic calcium
phosphate and are ISO 10993-1 tested to confirm the material's
biocompatibility.
The submitted mechanical testing data demonstrated that the
degradation shear strength, through 16 weeks, of the proposed
devices meets or exceeds the shear strength of the predicate
device. | |
| | Based on the indication for use, technological characteristics, and
the comparison to the predicate devices, Arthrex, Inc. has
determined that the Arthrex BioComposite TransFix are
substantially equivalent to currently marketed predicate devices. | |
Page 1 of 2
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1
K11 2040
Arthrex SPECIAL 510(k): Arthrex BioComposite TransFix
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Incorporated % Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
DEC 1 5 2011
Re: K112040
Trade/Device Name: Arthrex Biocomposite Transfix Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: November 16, 2011 Received: November 17, 2011
Dear Ms. Smith:
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 misJeading.
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
3
Page 3 - Ms. Courtney Smith
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/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/ReportalProblem/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 yours,
Sincerely yours,
N. Malkerson, oes
Mark N. Melkerson Director Division of Surgical. Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KII 2040
Arthrex SPECIAL 510(k): Arthrex BioComposite Tr
Indications for Use
510(k) Number (if known): K112040
Device Name: Arthrex BioComposite TrunsFix
Indications For Use:
The Arthrex BioComposite TransFix is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Fixation with the BioComposite TransFix is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically;
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Knee: Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Hand/Wrist: Ligament Scapholunate Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
Prescription Use_X_AND/OR Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW. THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Device
510(k) Number K11204