(189 days)
Not Found
No
The document describes a mechanical fixation system and its components, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is intended to provide temporary stabilization to aid in the repair of bone fractures and correct spinal deformities, which are therapeutic medical purposes.
No
The device is a fixation system consisting of temporary implants for use in orthopedic surgery, intended to provide temporary stabilization and aid in bone fracture repair. It is a therapeutic device, not a diagnostic one, as it does not diagnose, monitor, or detect medical conditions.
No
The device description explicitly states that the SILC™ Fixation System consists of physical components (bands, clamps, and surgical instruments) made from various metals and polymers. It is a hardware-based implant system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- SILC™ Fixation System Function: The SILC™ Fixation System is a system of temporary implants used within the body during orthopedic surgery to provide stabilization and aid in bone repair. It is a surgical implant, not a diagnostic test.
The provided information clearly describes a surgical device intended for implantation, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The SILC™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar, interspinous or facet wiring . techniques:
- Spinal reconstructive surgery, incorporated into constructs for the purpose . of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions. .
The SILC™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
Product codes
OWI
Device Description
The SILC™ Fixation System consists of bands, clamps that mate with 4.5mm-6.5mm diameter rods, and associated manual surgical instruments. Bands are manufactured from polyethylene terephthalate (PET) with commercially pure titanium tips per ASTM F67, and clamps are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F138, F1295, F1472, and F1537. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium molybdenum alloy implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
patients 8 years of age and older
Intended User / Care Setting
orthopedic surgery
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)
Mechanical testing (static band tension, static and dynamic band pull-through, static axial grip, and static torsion grip) was conducted in accordance with ASTM F1798 and the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004. Performance data demonstrate substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060009, K110348, K112736, K922952
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
510(k) Summary: SILC™ Fixation System
MAY 2 1 2014
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403 |
|--------------|-------------------------------------------------------------------------|
| 610-930-1800 | |
Christina Kichula Contact: Group Manager, Regulatory Affairs
- Date Prepared: November 12, 2013
SILC™ Fixation System Device Name:
Per 21 CFR as follows: Classification: &888.3010 Bone Fixation Cerclage, Sublaminar Product Codes OWI Regulatory Class II, Panel Code 87
- Zimmer Spine Universal Clamp Spinal Fixation System, Predicate(s): K060009. K110348 Medicrea LigaPASS, K112736 Pioneer Songer Cable System, K922952
Purpose:
The purpose of this submission is to request clearance of the SILC™ Fixation System.
DEVICE DESCRIPTION:
The SILC™ Fixation System consists of bands, clamps that mate with 4.5mm-6.5mm diameter rods, and associated manual surgical instruments. Bands are manufactured from polyethylene terephthalate (PET) with commercially pure titanium tips per ASTM F67, and clamps are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F138, F1295, F1472, and F1537. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium molybdenum alloy implants.
INDICATIONS FOR USE:
The SILC™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar, interspinous or facet wiring . techniques:
- Spinal reconstructive surgery, incorporated into constructs for the purpose . of correction of spinal deformities such as idiopathic and neuromuscular
1
scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions. .
The SILC™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
Performance Data:
Mechanical testing (static band tension, static and dynamic band pull-through, static axial grip, and static torsion grip) was conducted in accordance with ASTM F1798 and the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s," May 3, 2004. Performance data demonstrate substantial equivalence to the predicate devices.
Conclusions / Basis of Substantial Equivalence:
The SILC™ Fixation System implants are similar to the predicate implants with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. The SILC™ Fixation System performs as well as or better than the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2014
Globus Medical. Incorporated Ms. Christina Kichula Group Manager, Regulatory Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K133482
Trade/Device Name: SILC™ Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: April 21, 2014 Received: April 22, 2014
Dear Ms. Kichula:
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
3
· Page 2 - Ms. Christina Kichula
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 contact the Division of Industry and Consumer Education 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. 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/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 Industry and Consumer Education 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.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K133482 510(k) Number:
SILC™ Fixation System Device Name:
INDICATIONS:
The SILC™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar, interspinous or facet wiring . techniques:
- Spinal reconstructive surgery, incorporated into constructs for the purpose ● of correction of spinal deformities such as idiopathic and neuromuscular scollosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions. .
OR
The SILC™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
x Prescription Use (Per 21 CFR §801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
James P. Bertram -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133482