(185 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is described as a temporary implant for use in orthopedic surgery intended to provide stabilization, aid in the repair of bone fractures, and support bone fusion, which are all therapeutic functions.
No
The device is a temporary orthopedic implant used for stabilization during spinal fusion and fracture repair, not for diagnosing medical conditions.
No
The device description explicitly states it is a temporary orthopedic implant made of stainless steel and titanium, including a woven polyester band and locking screw. These are physical hardware components, not software.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes the Universal Clamp® Spinal Fixation System as a temporary implant used in orthopedic surgery to provide mechanical stabilization to the spine. It is a physical device that is surgically implanted into the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition. Its function is purely structural and supportive.
Therefore, based on the provided information, the Universal Clamp® Spinal Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Universal Clamp® Spinal Fixation System is a temporary implant 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 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 Universal Clamp® Spinal 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 Universal Clamp® Spinal Fixation System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical device implants made of either stainless steel or titanium whenever "wiring" may help secure the attachment of other implants.
The Universal Clamp® is available in both stainless steel and titanium versions. The stainless steel clamp is available in 3 sizes: 5.5, 6.0 and 6.35mm. The titanium clamp is available in 2 sizes of 5.5 and 6.0 mm. The different sizes are designed for compatibility with rods of the same sizes. A woven polyester band and locking screw are also provided.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Universal Clamp® Spinal Fixation System K091190, K081622, K060009, DePuy AcroMed ISOLA System K962984, Medtronic CD Horizon Spinal System K091445, Synthes USS Small Stature K994121, Luque Segmental Spinal Instrumentation K913561
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
AUG 1 1 2011
Image /page/0/Picture/1 description: The image shows the logo for Zimmer Spine. The logo features a stylized letter "Z" inside of a circle. Below the circle are the words "zimmer" and "spine" stacked on top of each other, with "zimmer" being larger and bolder than "spine".
510(k) SUMMARY Universal Clamp Spinal Fixation System
510(k) Number ________________________________________________________________________________________________________________________
| Date of Summary Preparation: | August 3, 2011 |
|---|---|
| Submitter: | Zimmer Spine, Inc. |
| 7375 Bush Lake Road | |
| Minneapolis, MN 55439 | |
| Company Contact: | Elsa A. Linke |
| Regulatory Affairs | |
| Manufacturer: | Zimmer Spine |
| Cité Mondiale | |
| 23 Parvis des Chartrons | |
| 33080 Bordeaux | |
| France | |
| Device Name: | Universal Clamp® Spinal Fixation System |
| Common Name: | Spinal Fixation System |
| Classification Name: | Bone Fixation, Cerclage |
| Product Code: | OWI |
| Regulation Number: | 21 CFR 888.3010 |
| Device Classification: | Class II |
| Predicate Devices: | Universal Clamp® Spinal Fixation System K091190. |
| K081622, K060009 | |
| DePuy AcroMed ISOLA System K962984 | |
| Medtronic CD Horizon Spinal System K091445 | |
| Synthes USS Small Stature K994121 | |
| Luque Segmental Spinal Instrumentation K913561 |
Description of Device:
The Universal Clamp® Spinal Fixation System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical device implants made of either stainless steel or titanium whenever "wiring" may help secure the attachment of other implants.
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K110348 page 2 of 2
The Universal Clamp® is available in both stainless steel and titanium versions. The stainless steel clamp is available in 3 sizes: 5.5, 6.0 and 6.35mm. The titanium clamp is available in 2 sizes of 5.5 and 6.0 mm. The different sizes are designed for compatibility with rods of the same sizes. A woven polyester band and locking screw are also provided.
Intended Use:
The Universal Clamp® Spinal Fixation System is a temporary implant 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 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 Universal Clamp Spinal 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.
Comparison of Technological Characteristics:
The Universal Clamp® Spinal Fixation System is like the predicate devices in that through seqmental fixation it stabilizes the spine as an adjunct to fusion in the correction of spinal deformities.
Substantial Equivalence:
A review of the clinical literature establishes that the Universal Clamp® Spinal Fixation System is substantially equivalent to the predicate devices in its safety and effectiveness profile in the treatment of pediatric scoliosis patients.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer Spine, Inc. % Ms. Elsa Linke 7375 Bush Lake Road Minneapolis, Minnesota 55439
AUG 1 1 2011
Re: K110348
Trade/Device Name: Universal Clamp® Spinal Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: August 03, 2011 Received: August 04, 2011
Dear Ms. Linke:
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
3
Page 2 - Ms. Elsa Linke
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 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.goy/AboutFDA/CentersOffices/CDRH/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/Reportal?roblem/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 vor
ton Del. D.L. D.L.
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 Statement
510(k) Number (if known): _ K II O348
Device Name: Universal Clamp® Spinal Fixation System
Indications for Use:
The Universal Clamp® Spinal Fixation System is a temporary implant 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 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 Universal Clamp® Spinal 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.
Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________
R Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
_
(Division Sign-Off)_
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ KII0348