(98 days)
Not Found
No
The document describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a temporary orthopedic implant used to provide stabilization during the development of bony fusion and aid in the repair of bone fractures, which directly relates to treating a medical condition.
No
The device is described as a temporary implant for stabilization and repair of bone fractures, not for diagnosis.
No
The device description clearly states it is a "temporary orthopedic implant" and a "temporary implant for use in orthopedic surgery," indicating it is a physical hardware device.
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 Stainless Steel System as a temporary implant used in orthopedic surgery for stabilization and repair of bone fractures and spinal fusions. It is physically implanted into the body.
Therefore, based on the provided information, the device is an implantable surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Universal Clamp Stainless Steel 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 implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.
The Universal Clamp Stainless Steel System is a temporary orthopedic 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. interspinous, or facet wiring techniques.
- Spinal reconstructive surgery, incorporated into 2. constructs for the purpose of correction of spinal deformities such as scoliosis, kvohosis. spondylolisthesis.
-
- Spinal degenerative surgery, as an adjunct to spinal fusions;
The Universal Clamp Stainless Steel System may also be used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.
The Universal Clamp Stainless Steel 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 factures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring 1 techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of 2. correction of spinal deformities such as scoliosis, kyphosis, spondylolisthesis;
- റ്റ് Spinal degenerative surgery, as an adjunct to spinal fusions;
The Universal Clamp Stainless Steel System may also be used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.
Product codes (comma separated list FDA assigned to the subject device)
JDQ
Device Description
The Universal Clamp Stainless Steel 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 implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering evaluations and bench testing were conducted to assess the physical and mechanical properties of the subject device. These results demonstrate that the performance of the Abbott Spine Universal Clamp® Stainless Steel System is substantially equivalent to the predicate stainless steel version cleared under premarket notification K081622.
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.
Not Found
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
§ 888.3010 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
Zimmer Spine SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTER:
Zimmer Spine
JUL 30 2009
3003853072
David Padgett, RAC (US) Senior Specialist, Regulatory Affairs Telephone: (512) 533-1998 Fax: (512) 258-0995
June 30, 2009
Universal Clamp® Stainless Steel System
JDQ
Bone Fixation Cerclage
21 CFR § 888.3010
Abbott Spine Universal Clamp Stainless Steel System
The Universal Clamp Stainless Steel 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 implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.
The Universal Clamp Stainless Steel System is a temporary orthopedic 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. interspinous, or facet wiring techniques.
- Spinal reconstructive surgery, incorporated into 2. constructs for the purpose of correction of spinal deformities such કર scoliosis, kvohosis. spondylolisthesis.
-
- Spinal degenerative surgery, as an adjunct to spinal fusions;
The Universal Clamp Stainless Steel System may also be used in conjunction with other medical implants made
CONTACT PERSON:
TRADE NAME:
Date:
Product Code:
CLASSIFICATION NAME:
Classification Reference:
MANUFACTURER ESTABLISHMENT
REGISTRATION NUMBER:
PREDICATE DEVICE:
DEVICE DESCRIPTION:
INDICATIONS:
1
of stainless steel whenever "wiring" may help secure the attachment of other implants.
COMPARISON TO PREDICATE DEVICE:
Engineering evaluations and bench testing were conducted to assess the physical and mechanical properties of the subject device. These results demonstrate that the performance of the Abbott Spine Universal Clamp® Stainless Steel System is substantially equivalent to the predicate stainless steel version cleared under premarket notification K081622.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a seal or emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 2009
Zimmer Spine % Mr. David Padgett, RAC Senior Specialist, Regulatory Affairs 5301 Riata Park Court, Building F Austin, TX, 78727
Re: K091190
Trade/Device Name: Clamp® Stainless Steel System Regulation Number: 21 CFR 888.3010 · Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: June 30, 2009 Received: July 2, 2009
Dear Mr. Padgett:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 - Mr. David Padgett, RAC
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Harbara Buchus
fris
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
510(k) Number (if known): K091190
Device Name:
Universal Clamp® Stainless Steel System
Indications for Use:
The Universal Clamp Stainless Steel 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 factures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring 1 techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of 2. correction of spinal deformities such as scoliosis, kyphosis, spondylolisthesis;
- റ്റ് Spinal degenerative surgery, as an adjunct to spinal fusions;
The Universal Clamp Stainless Steel System may also be used in conjunction with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDBH. Office of Device Evaluation (ODE) (ExT forma) (Division Sign-Off) Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K091190