NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
Device Facts
| Record ID | K120356 |
|---|---|
| Device Name | NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD |
| Applicant | Ncs Lab Srl |
| Product Code | MBI · Orthopedic |
| Decision Date | Dec 11, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The NCS Fish-Fit MD System is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tendons lesions with the purpose of repairing the rotator cuff (supraspinatus, infraspinatus and subscapularis).
Device Story
NCS Fish-Fit MD System comprises sterile, single-use titanium grade 4 implantable suture anchors and reusable Compass MD surgical instruments. Used by orthopedic surgeons in clinical settings (OR) for rotator cuff repair. Device implanted into pre-drilled bone cavity to secure tendons to bone during healing. Provides mechanical fixation of soft tissue to bone. Benefits patient by facilitating anatomical reattachment of torn tendons, supporting recovery from rotator cuff injuries.
Clinical Evidence
Bench testing only. Performance verified via fixation strength and pull-out strength testing in accordance with FDA guidance document 'Guidance Document for Testing Bone Anchor Devices' (April 20, 1996). No clinical data provided.
Technological Characteristics
Titanium grade 4 implantable anchor; reusable stainless steel instrumentation. Mechanical fixation principle. Dimensions and design similar to predicate anchors. Non-active, non-software device.
Indications for Use
Indicated for adults requiring surgical repair of rotator cuff tendon lesions (supraspinatus, infraspinatus, subscapularis) via attachment of soft tissue to bone in arthroscopic or open procedures.
Regulatory Classification
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.
Predicate Devices
- Smith and Nephew, TwinFix Ultra Ti Suture Anchor (K100159)
- ConMed Linvatex, Y-Knot All-Suture Anchor (K111779)
Submission Summary (Full Text)
{0}------------------------------------------------
## 510(k) Summary
## NCS Fish-Fit MD System
# DEC 1 1 2012
000078
K120356
Submitted by:
1.
NCS Lab Srl Via Pola Esterna 4/12 41012 Carpi (MO) Italy
Contact Person:
Matteo Mantovani Technical Director Telephone: +39 (059) 669813 Fax: +39 (059) 669813
Preparation:
November 27, 2012
2. Device Name and Classification Information:
## Trade/Proprietary Name:
NCS Fish-Fit MD System, which consists of the following:
- 1) the Fish-Fit MD, a sterile, single use, implantable suture anchor; and,
{1}------------------------------------------------
2) the Compass MD, a series of reusable surgical
instruments used to implant the Fish-Fit MD.
### Common/Usual Name:
Anchor
Orthopedic Manual Surgical Instruments
Classification Information
NCS Fish-Fit MD System
Classification Name: Smooth or Threaded Metallic Bone Fixation Fastener
Classification Regulation: 21 CFR 888.3040
Regulatory Class: II
Product Code: MBI - Fastener, Fixation, Nondegradable, Soft Tissue
#### 3. Predicate Devices
The NCS Fish-Fit MD System is substantially equivalent to the following predicate devices:
- Smith and Nephew, TwinFix Ultra Ti Suture Anchor, . cleared by FDA on April 19, 2010 in K100159; and
- ConMed Linvatex, Y-Knot All-Suture Anchor, cleared by . FDA on August 8, 2011 in K111779.
2
000079
{2}------------------------------------------------
#### Description of the Device 4.
NCS Fish-Fit MD System is an implantable anchor made from Titanium grade 4. Sutures are not pre-assembled with bone anchor. The system includes an instrumentation package, Compass MD. The instrument package is intended to facilitate implantation of the anchor.
#### 5. Intended Use and Indications for Use
The NCS Fish-Fit MD System is intended for use for the reattachment of soft tissue (tendons) to bone in the shoulder for rotator cuff repairs. The device has the following indications for use:
> The NCS Fish-Fit MD System is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tendons lesions with the purpose of repairing the rotator cuff (supraspinatus, infraspinatus and subscapularis).
#### ે. Comparison to the Predicate Devices
The NCS Fish-Fit MD System is substantially equivalent to the legally marketed predicate devices. The NCS Fish-Fit MD System
{3}------------------------------------------------
and its predicate devices are all smooth or threaded metallic bone fixation fastener as defined in 21 CFR 888.3040.
The NCS Fish-Fit MD System has the same intended use as both predicate devices. All three devices are intended for use during arthroscopic or open surgeries to repair rotator cuff injuries. All three devices serve the same primary function: namely, to secure the tendons to bone during healing. All three devices are used by the same health care providers (orthopedic surgeons) in the same target patient population: adults who require repair of rotator cuff injuries. All devices are implanted into a cavity drilled into the bone.
All three devices share similar design features, including materials, similar sizes and dimensions, and insertion into a pre-drilled cavity into the bone. Each device utilizes a slightly different design to fix the anchor to the bone. Data have been provided to show that the NCS Fish-Fit MD System and Bone Anchor perform as well as the predicate device with respect to fixation strength and pull-out strength. These data have been provided in accordance with the FDA guidance document entitled "Guidance Document for Testing Bone Anchor Devices" dated April 20, 1996 to show that the NCS Fish-Fit MD System.
The provided non-clinical testing has been performed to verify adequate fixation strength and pull-out performances of the device, demonstrating substantially equivalence to the predicate devices.
1
{4}------------------------------------------------
# Conclusion 7.
:
1. Sales of the same .
י
·
Based upon the similarities in performances, materials and intended uses, NCS Fish Fit MD System is substantially equivalent to the : predicate devices.
:
.
.
. .
000082
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized, and the overall appearance is clean and professional.
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
Letter dated: December 11, 2012
NCS Lab SRL % Mr. Matteo Mantovani Technical Director Via Pola Esterna 4/12 Carpi, Italy 41012
Re: K120356
Trade/Device Name: NCS Fish-Fit MD System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 27, 2012 Received: November 29, 2012
Dear Mr. Mantovani:
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
{6}------------------------------------------------
Page 2 – Mr. Matteo Mantovani
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/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,
# Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
# Indications for Use
510(k) Number:
K120356
Device Name:
NCS Fish-Fit MD System
Indications For Use:
The NCS Fish-Fit MD System is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tendons lesions with the purpose of repairing the rotator cuff (supraspinatus, infraspinatus and subscapularis).
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(Part 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) Casey Hanley
> > For Division of Orthopaedic Devices
