(118 days)
No
The summary describes a mechanical implant system for reattaching soft tissue to bone and does not mention any AI or ML components.
Yes
The device is used to reattach soft tissue to bone to stabilize damaged soft tissue throughout the healing period, which aligns with the definition of a therapeutic device.
No
The device is an implant system used to reattach soft tissue to bone during surgical procedures, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it consists of physical components like suture anchors, a broaching punch, and a suture passing loop, which are hardware.
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 surgical implant system used to reattach soft tissue to bone. This is a therapeutic and structural function within the body.
- Indications for Use: The indications are for specific orthopedic surgical procedures (rotator cuff repair, Achilles repair) in specific joints (shoulder, ankle). This further reinforces its use in surgical intervention.
- Device Description: The description details physical components like suture anchors, drivers, punches, and loops, all designed for surgical implantation and manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality. The device itself is implanted and acts mechanically.
IVD devices are used outside the body to examine specimens and provide diagnostic information. This device is used inside the body for surgical repair.
N/A
Intended Use / Indications for Use
INTENDED USE
The Implant System may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
INDICATIONS FOR USE
The CuffLinkTM Implant System Biocomposite is indicated to reattach soft tissue to bone in the following orthopedic surgical procedures.
| Procedure | Joint |
|---|---|
| Rotator cuff repair | Shoulder |
| Achilles Repair | Ankle |
Product codes (comma separated list FDA assigned to the subject device)
MAI, MBI
Device Description
The CuffLink™ Implant System Biocomposite consists of six kits that are provided sterile, for single-use only. Each kit contains four (4) suture anchors in various combinations of the CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (K171592) and Y-Knot RC All-Suture Anchor (K133224). Two (2) of the anchors are meant to be used as the primary/medial row and two (2) anchors are meant to be used for the knotless/lateral row. Each kit also contains one (1) disposable broaching punch, and one (1) suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
arthroscopic or open surgical procedures
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 has been completed to demonstrate that the Cufflink™ Implant System Biocomposite performs as intended and is substantially equivalent to the predicate device. The bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes biocompatibility, packaging, user validation, shelf life, sterilization, transportation, and pyrogenicity.
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.
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.
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CONMED Corporation Diana L. Nader-Martone Regulatory Affairs Specialist 525 French Road Utica, New York 13502
July 19, 2018
Re: K180763
Trade/Device Name: CuffLink Implant System Biocomposite Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: June 15, 2018 Received: June 18, 2018
Dear Ms. Nader-Martone:
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 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);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020 See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
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510(k) Number (if known)
Device Name CuffLink Implant System Biocomposite
Indications for Use (Describe)
INTENDED USE
The Implant System may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
INDICATIONS FOR USE
The CuffLinkTM Implant System Biocomposite is indicated to reattach soft tissue to bone in the following orthopedic surgical procedures.
| Procedure | Joint |
|---|---|
| Rotator cuff repair | Shoulder |
| Achilles Repair | Ankle |
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)
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510(k) SUMMARY
- l. SUBMITTER
CONMED Corporation 525 French Road Utica, NY 13502
| Phone: | 727.399.5425 |
|---|---|
| Fax: | 727.399.5264 |
Diana L. Nader-Martone Contact Person: Date Prepared: June 15, 2018
- II. DEVICE
| Device Name: | CuffLinkTM Implant System Biocomposite |
|---|---|
| Trade Name/Common Name: | Bioabsorbable Suture Anchor |
| Classification Name: | Fastener, fixation, biodegradable, soft tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888.3030 |
| Product Code: | MAI, MBI |
III. PREDICATE DEVICE
CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver Device Name: Manufacturer: CONMED Corporation 510(k) Number: K171592
- IV. REFERENCE DEVICE
| Device Name: | CuffLink™ Implant System |
|---|---|
| Manufacturer: | CONMED Corporation |
| 510(k) Number: | K171725 |
V. DEVICE DESCRIPTION
The CuffLink™ Implant System Biocomposite consists of six kits that are provided sterile, for single-use only. Each kit contains four (4) suture anchors in various combinations of the CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (K171592) and Y-Knot RC All-Suture Anchor (K133224). Two (2) of the anchors are meant to be used as the primary/medial row and two (2) anchors are meant to be used for the knotless/lateral row. Each kit also contains one (1) disposable broaching punch, and one (1) suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch.
- VI. INTENDED USE/INDICATIONS FOR USE STATEMENT
INTENDED USE
The Implant System may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the
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damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
INDICATIONS FOR USE
The CuffLink™ Implant System Biocomposite is indicated to reattach soft tissue to bone in the following orthopedic surgical procedures.
| Procedure | Joint |
|---|---|
| Rotator Cuff Repair | Shoulder |
| Achilles Repair | Ankle |
- VII. COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
CONMED's CuffLink Implant System Biocomposite is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the CONMED CrossFT Knotless Biocomposite Suture Anchor (predicate device (K171592)) with Disposable Driver and CuffLink™ Implant System (reference device (K171725)) and raises no new issues of safety or effectiveness.
The similarities and differences between the proposed, predicate, and reference devices are summarized in the table below.
| Proposed Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Device | CuffLink™ Implant System | ||
| Biocomposite | CrossFT™ Knotless | ||
| Biocomposite Suture | |||
| Anchor with Disposable | |||
| Driver | CuffLink™ Implant | ||
| System | |||
| 510(k) Number | K171592 | K171725 | |
| Manufacturer | CONMED Corporation | ||
| Intended Use | The Implant System may | ||
| be used in either | |||
| arthroscopic or open | |||
| surgical procedures. After | |||
| the suture is anchored to | |||
| the bone, it may be used | |||
| to reattach soft tissue, | |||
| such as ligaments, | |||
| tendons, or joint capsules | |||
| to the bone. The suture | |||
| anchor system thereby | |||
| stabilizes the damaged | |||
| soft tissue, in conjunction | |||
| with appropriate | |||
| postoperative | |||
| immobilization, | The biocomposite suture | ||
| anchor is intended to | |||
| reattach soft tissue to bone | |||
| in the following orthopedic | |||
| surgical procedures: |
Procedure Joint
Rotator cuff repair Shoulder
Achilles Repair Ankle
Biceps Tenodesis Shoulder
Gluteus Medius Repair Hip
Medial Patellofemoral Knee
Ligament (MPFL) | The CuffLink™ Implant
System is intended to
reattach soft tissue to
bone in orthopedic
surgical procedures. |
| | throughout the healing
period. | | |
| Indications for Use | The CuffLink™ Implant
System Biocomposite is
indicated to reattach soft
tissue to bone in the
following orthopedic
surgical procedures.
Procedure
Joint
Rotator Cuff Repair Shoulder
Achilles Repair Ankle | The device may be used in
either arthroscopic or open
surgical procedures. After
the suture is anchored to
the bone, it may be used to
reattach soft tissue, such as
ligaments, tendons, or joint
capsules to the bone. The
suture anchor system
thereby stabilizes the
damaged soft tissue, in
conjunction with appropriate
postoperative
immobilization, throughout
the healing period. | The Implant System may
be used in either
arthroscopic or open
surgical procedures. After
the suture is anchored to
the bone, it may be used
to reattach soft tissue,
such as ligaments,
tendons, or joint capsules
to the bone. The suture
anchor system thereby
stabilizes the damaged
soft tissue, in conjunction
with appropriate
postoperative
immobilization,
throughout the healing
period. |
| | Proposed Device | Predicate Device | Reference Device |
| Device | CuffLink™ Implant System
Biocomposite | CrossFT™ Knotless
Biocomposite Suture
Anchor with Disposable
Driver | CuffLink™ Implant
System |
| Contraindications | 1. Pathological conditions
of bone which would
adversely affect the
CuffLink™ Implant
System Biocomposite.
2. Pathological conditions
in the soft tissue to be
repaired or reconstructed
which would adversely
affect suture fixation.
3. Physical conditions
that would eliminate, or
tend to eliminate,
adequate implant support
or retard healing. | 1. Pathological conditions
of bone which would
adversely affect the
CrossFT™ Knotless
Biocomposite Suture
Anchor.
2. Pathological conditions
in the soft tissue to be
repaired or reconstructed
which would adversely
affect suture fixation.
3. Physical conditions that
would eliminate, or tend to
eliminate, adequate
implant support or retard
healing. | 1. Pathological
conditions of bone which
would adversely affect
the CuffLink™ Implant
System.
2. Pathological
conditions in the soft
tissue to be repaired or
reconstructed which
would adversely affect
suture fixation.
3. Physical conditions
that would eliminate, or
tend to eliminate,
adequate implant
support or retard
healing. |
| | 4. Conditions which tend
to limit the patient's
ability or willingness to
restrict activities or follow
directions during the | 4. Conditions which tend
to limit the patient's ability
or willingness to restrict
activities or follow | 4. Conditions which tend
to limit the patient's
ability or willingness to |
| | healing period. | directions during the | restrict activities or follow |
| | 5. Attachment of artificial | healing period. | directions during the
healing period. |
| | ligaments or other
implants.
6. Foreign body | 5. Attachment of artificial
ligaments or other
implants. | 5. Attachment of artificial
ligaments or other
implants. |
| | sensitivity, known or
suspected allergies to
implant and/or instrument
materials. | 6. Foreign body sensitivity,
known or suspected
allergies to implant and/or
instrument materials. | 6. Foreign body
sensitivity, known or
suspected allergies to
implant and/or |
| | 7. This device is not
approved for screw | 7. This device is not
approved for screw | instrument materials. |
| | attachment or fixation to
the posterior elements
(pedicles) of the cervical,
thoracic or lumbar spine. | attachment or fixation to
the posterior elements
(pedicles) of the cervical,
thoracic or lumbar spine. | 7. This device is not
approved for screw
attachment or fixation to
the posterior elements
(pedicles) of the cervical,
thoracic or lumbar spine. |
| | Proposed Device | Predicate Device | Reference Device |
| Device | CuffLink™ Implant System
Biocomposite | CrossFT™ Knotless
Biocomposite Suture
Anchor with Disposable
Driver | CuffLink™ Implant
System |
| Reuse/Sterilization | Single-Use | | |
| Principle of
Operation | Soft tissue to bone fixation | | |
| Biocompatibility | In accordance with ISO 10993-1 and FDA # G95-1 | | |
| Packaging | Multiple implants in tray | Single device unit in
package | Multiple implants in tray |
| Materials | UHMWPE, polyester, nylon suture, stainless steel,
polycarbonate, 96L/4D co-polymer and β-TCP | | UHMWPE, polyester,
nylon suture, stainless
steel, polycarbonate,
PEEK Optima® |
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PERFORMANCE DATA VIII.
Testing has been completed to demonstrate that the Cufflink™ Implant System Biocomposite performs as intended and is substantially equivalent to the predicate device. The bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes biocompatibility, packaging, user validation, shelf life, sterilization, transportation, and pyrogenicity.
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CONCLUSION IX.
CONMED's Cufflink™ Implant System Biocomposite is either substantially equivalent or identical in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicate and reference devices. Based upon the findings of performance testing, the differences do not present any novel issues of safety and efficacy, and is substantially equivalent to the predicate device.