(80 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/ML.
Yes
The device is intended to provide temporary stabilization and aid in the repair of bone fractures during orthopedic surgery, which directly addresses a medical condition or ailment.
No
The provided text explicitly states the device is a "temporary implant for use in orthopedic surgery" intended to "provide temporary stabilization as a bone anchor" and "aid in the repair of bone fractures," rather than to diagnose medical conditions.
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 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.
- 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 aiding in bone repair. It is physically placed inside the body during surgery.
The device's function is entirely mechanical and structural, not related to analyzing biological samples.
N/A
Intended Use / 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, but are not limited to, 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 scoliosis, kyphosis, 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.
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
Spinal
Indicated Patient Age Range
Not Found
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)
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 titanium alloy version cleared in premarket notification K060009.
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
KU81622- 1 of 2
Submitter:
AUG 2 9 2008
ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS
Abbott Spine Inc.
| ESTABLISHMENT REGISTRATION
| NUMBER: | 1649384 |
|---|---|
| CONTACT PERSON: | Maritza Elias |
| Senior Regulatory Affairs Specialist | |
| Telephone: 512.533.1908 | |
| Fax: 512.918.2784 | |
| DATE: | August 28, 2008 |
| TRADE NAME: | Universal Clamp® Stainless Steel System |
| PRODUCT CODE: | JDQ |
| CLASSIFICATION NAME: | Bone Fixation Cerclage |
| CLASSIFICATION REFERENCE: | 21 CFR § 888.3010 |
| PREDICATE DEVICE: | Abbott Spine Universal Clamp System (Ti) |
| 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. | |
| INDICATIONS: | 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, but are not limited to, | |
| the following applications: |
- Spinal trauma surgery, used in sublaminar, 1. interspinous, or facet wiring techniques;
- Spinal reconstructive surgery, incorporated 2. into constructs for the purpose of correction
1
K081622 - 2 of 2
| 3. | of spinal deformities such as scoliosis, kyphosis, 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. | |
| SUBSTANTIAL EQUIVALENCE: | 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 titanium alloy version cleared in premarket notification K060009. |
.
. .
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2008
Abbott Spine, Inc % Ms. Maritza Elias Senior Regulatory Affairs Specialist 5301 Riata Park Court, Building F Austin, Texas 78727
Re: K081622
Trade/Device Name: Abbott Spine Universal Clamp® Stainless Steel System Regulation Number: 21 CFR 888.3010 Regulation Names: Bone fixation cerclage. Regulatory Class: II Product Code: JDQ Dated: August 01, 2008 Received: August 04, 2008
Dear Ms. Elias:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Maritza Elias
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K081622
Device Name:
Abbott Spine 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, but are not limited to, 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,
- Spinal degenerative surgery, as an adjunct to spinal fusions; റ്റ്
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)
C
(Please do not write below this line - Continue on another page if needed)
| Concurrence of CDRH, Office of Device | Evalua |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative |
and Neurological Devices
510(k) Number K081622