(137 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant and inserter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a PRO Fixation™ System intended for the reattachment of soft tissue to bone, which is a therapeutic function.
No
This device is intended for the reattachment of soft tissue to bone, which is a therapeutic function, not a diagnostic one. It is a surgical implant system designed for repair, not for identifying or investigating a disease or condition.
No
The device description explicitly states that the system is comprised of an implantable non-absorbable anchor and a disposable inserter, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for the surgical reattachment of soft tissue to bone in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as an "implantable non-absorbable anchor and a disposable inserter" used for "placement, suture tensioning, and fixation of soft tissue into bone." This aligns with a surgical implant and its delivery system.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on mechanical properties (pull-out strength, suture integrity) and biocompatibility, which are relevant for implantable devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended for the reattachment of soft tissue to bone in the shoulder, foot/ankle, knee, elbow and hand/wrist for the following indications:
Shoulder: Rotator Cuff Repair. 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, Mid-Foot Reconstruction. Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Temis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction and Repair, Tendon Transfer in the Hand/Wrist
Product codes
HWC, MBI
Device Description
The PRO Fixation™ System is a sterile single use device intended for the reattachment of soft tissue to bone. The PRO Fixation System is comprised of an implantable non-absorbable anchor and a disposable inserter. The anchor allows for placement, suture tensioning, and fixation of soft tissue into bone. Anchors will be available in a range of sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, elbow 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
Non-Clinical Testing: Testing has been conducted to evaluate the biological safety and performance characteristics of PRO Fixation™ System. Biocompatibility results indicate that the device biocompatibility profile is equivalent to the predicate devices. Laboratory testing was performed to verify that pull-out strength, suture integrity/tensile strength following anchor insertion, suture slip resistance, and anchor and driver integrity meet mechanical performance requirements for the product's intended use and are comparable to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K051219, K051726, K050358, K061665, K073509, K093897
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
JUL 1 2 2011
2
510(K) SUMMARY
l Submitter Information
| A. | Company Name: | Synovis Orthopedic and Woundcare, Inc |
|---|---|---|
| B. | Company Address: | 6 Jenner, Suite 150 |
| Irvine, CA 92618 | ||
| C. | Company Phone: | (949) 502-3240 |
| D. | Company Facsimile: | (949) 502-3241 |
| E. | Contact Person: | Amy Boucly |
| Manager, Regulatory Affairs | ||
| Device Identification |
| A. Device Trade Name: | PRO Fixation™ System |
|---|---|
| ----------------------- | ---------------------- |
- B. Common Name: Suture Anchor
- ੁੱ Classification Name(s): Screw, Fixation, Bone
- Classification Regulation: 888.3040 D.
- E. Device Class: Class II
- HWC, MBI ان . Device Code(s):
- ੁ. Advisory Panel: Orthopedic
Identification of Predicate Devices ﺪ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
The PRO Fixation™ System is substantially equivalent to the following devices, which are cleared for commercial distribution in the United States:
- · PushLock™, Arthrex, Inc., K051219
- · Arthrex Tenodesis Family, Arthrex, Inc, K051726
- · Corkscrew FT, Arthrex, Inc., K050358, K061665
- · FOOTPRINT Ultra PK Suture Anchor, Smith & Nephew, Inc., Endoscopy Division, K073509/ K093897
4 Device Description
The PRO Fixation™ System is a sterile single use device intended for the reattachment of soft tissue to bone. The PRO Fixation System is comprised of an implantable non-absorbable anchor and a disposable inserter. The anchor allows for placement, suture tensioning, and fixation of soft tissue into bone. Anchors will be available in a range of sizes.
1
77
KI10538
5 Statement of Intended Use
Intended for the reattachment of soft tissue to bone in the shoulder, foot/ankle, knee, elbow and hand/wrist for the following indications:
Shoulder: Rotator Cuff Repair. 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, Mid-Foot Reconstruction. Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Temis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction and Repair, Tendon Transfer in the Hand/Wrist
6 Non-Clinical Testing
Testing has been conducted to evaluate the biological safety and performance characteristics of PRO Fixation™ System.
Biocompatibility results indicate that the device biocompatibility profile is equivalent to the predicate devices.
Laboratory testing was performed to verify that pull-out strength, suture integrity/tensile strength following anchor insertion, suture slip resistance, and anchor and driver integrity meet mechanical performance requirements for the product's intended use and are comparable to predicate devices.
7 Comparison with Predicate Devices
The PRO Fixation™ System is comparable to the predicate devices in terms of intended use, technology, design, materials and biocompatibility and performance: It is similar to the predicate devices in that it has the same intended use of soft tissue to bone reattachment. is comprised of similar materials and is similar in design. All test results demonstrated that the performance of PRO Fixation™ System is equivalent to the predicate devices.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Synovis Orthopedic and Woundcare, Inc. % Ms. Amy Boucly 6 Jenner Street Suite 150 Irvine, CA 92618 .
JUL 1 2 2011
Re: . K110538
Trade/Device Name: PRO Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI Dated: June 17. 2011 Received: June 20, 2011
Dear Ms. Boucly:
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
3
Page 2 - Ms. Amy Boucly
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 (OS) 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/ucm] 15809.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.html
Sincerely yours. Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): KIIO538
Device Name:
PRO Fixation™ System
Indications for Use:
Intended for the reattachment of soft tissue to bone in the shoulder, foot/ankle, knee, elbow and hand/wrist for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Scparation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Revair, Hallux Valgus Reconstruction, Mid-Foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction and Repair, Tendon Transfer in the Hand/Wrist
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K110538 |
|---|---|
| --------------- | --------- |