(92 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a "temporary implant for use in orthopedic surgery" providing "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures," which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is a temporary implant for spinal fixation, used during orthopedic surgery to provide stabilization and aid in bone fracture repair. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components made of implantable grade metals (woven band, guiding section, metal buckles, metal clamps, locking screw), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided text clearly describes a surgical implant used within the body to stabilize the spine. It's a physical device that is surgically placed.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
This device is a Class II medical device (based on the K numbers and the nature of the implant) used in orthopedic surgery.
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 System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.
Product codes
OWI
Device Description
The Universal Clamp Spinal Fixation System consists of a woven band with a stiff guiding section at one end and metal buckles at the other end, implantable grade metal clamps that mate with 4.5mm - 6.35mm diameter rods, and an implantable grade metal locking screw that tightens the clamp over the band securing it to the connecting rod.
lmplants made from implantable grade titanium, implantable grade titanium alloy, and implantable grade cobalt chromium may be used together. Due to the risk of galvanic corrosion, never use titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances.
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
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
Performance testing (static axial pushdown, static axial rotation, static axial tension, and dynamic tension) was conducted to in accordance with ASTM F1798. All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems.
Key Metrics
Not Found
Predicate Device(s)
K110348, K091190, S€1 FÎ GGÊ K060009, K974020
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol consisting of three abstract human profiles facing right, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2014
Zimmer Spine, Incorporated Ms. Holly Seppanen Regulatory Affairs Project Manager 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K142053
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 7, 2014 Received: August 8, 2014
Dear Ms. Seppanen:
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
1
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 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/Resourcesfor You/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/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 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. Dean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142053
Device Name
Universal Clamp Spinal Fixation System
Indications for Use (Describe)
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 System may also be used in conjunction with other medical grade implants metals whenever "wiring" may help secure the attachment of the other implants.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Image /page/3/Picture/1 description: The image shows the logo for Zimmer Spine. The logo consists of a blue circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in blue, with a line underneath it. Below the line, the word "spine" is written in a smaller font size, also in blue.
510(k) SUMMARY
Universal Clamp® Spinal Fixation System
| Date of Summary Preparation: | October 21, 2014 |
|---|---|
| Company: | Zimmer Spine, Inc. |
| Cité Mondiale | |
| 23, Parvis des Chartrons | |
| 33080 Bordeaux, France | |
| Establishment Registration Number: | 3003853072 |
| Company Contact: | Holly Seppanen |
| Regulatory Affairs Project Manager | |
| Email: Holly.Seppanen@zimmer.com | |
| Office: 952.830.6240 | |
| Trade Name(s): | Universal Clamp Spinal Fixation System |
| Device Name (Common Name): | Spinal Fixation System |
| Device Classification: | Class II |
| Regulation Number and | |
| Product Code(s): | 21 CFR § 888.3010 / OWI |
| Regulation Name: | Bone fixation cerclage |
| Predicate(s): | Zimmer Spine Universal Clamp Spinal Fixation |
| System (K110348*, K091190, S€1 FÎ GGÊ | |
| K060009) | |
| Spinal Concepts CFIX Cable System | |
| (K974020) | |
| *df]a UfmdfYX]WURY |
General Device Description:
The Universal Clamp Spinal Fixation System consists of a woven band with a stiff guiding section at one end and metal buckles at the other end, implantable grade metal clamps that mate with 4.5mm - 6.35mm diameter rods, and an implantable grade metal locking screw that tightens the clamp over the band securing it to the connecting rod.
lmplants made from implantable grade titanium, implantable grade titanium alloy, and implantable grade cobalt chromium may be used together. Due to the risk of galvanic corrosion, never use titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances.
4
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 System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.
Summary of Performance Testing:
Performance testing (static axial pushdown, static axial rotation, static axial tension, and dynamic tension) was conducted to in accordance with ASTM F1798. All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems.
Substantial Equivalence:
The subject Zimmer Spine Universal Clamp Spinal Fixation System configurations are similar to predicate devices with respect to intended use, mechanical and functional performance and technological characteristics. The information contained in this submission show that the subject Universal Clamp Spinal Fixation System is substantially equivalent to the predicate devices.