(89 days)
87 KWP, 87KWQ, 87MNH, 87MNI
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 intended to immobilize and stabilize spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, which is a therapeutic function.
No
The device is described as a spinal fixation system intended to provide immobilization and stabilization of spinal segments, primarily for treatment after a diagnosis has already been made. It is a surgical implant, not a tool for identifying or characterizing a medical condition.
No
The device description explicitly states that the device consists of physical components manufactured from titanium alloy, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing and fusing the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a mechanical component (adaptor, set screw, connector) made of titanium alloy, designed for physical attachment within the body. This is consistent with a surgical implant.
- No Mention of In Vitro Testing: There is no mention of the device being used to test samples (blood, tissue, etc.) outside of the body, which is the defining characteristic of an in vitro diagnostic device.
- Performance Studies: The performance studies mentioned are mechanical testing, which is relevant for a physical implant, not for evaluating the accuracy of a diagnostic test.
In summary, the Xia™ Spinal System is a surgical implant intended for therapeutic use in the spine, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Xia™ Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia™ Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar-first sacral (L5-S1) vertebral joint which is fused; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screw fixation is limited to L3 to S1 or the ilium.
When used as a pedicle screw fixation system, the Xia™ Spinal System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (psuedoarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac fixation system, the Xia™ Spinal System is indicated for patients with degenerative disc disease of the thoracic, lumbar, which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, tumor, psuedoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia™ Spinal System is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia™ Spinal System is indicated for use in the thoracic and lumbar spine.
Product codes
87 KWP, 87KWQ, 87MNH AND 87MNI
Device Description
The Xia™ Spinal System C-C Adaptor is a line extension to the Xia™ Spinal System. It consists of a C-C Adaptor with a set screw. The Xia™ Spinal System C-C Adaptor is a lateral connector. When used with a Xia™ Spinal System I-Connector, it allows for attachment of a hook to the longitudinal rod. The components are manufactured from titanium alloy.
The subject components, Howmedica Osteonics® Xia™ Spinal System C-C Adaptor, are single-use devices which are sold non-sterile and are intended for use only with the other titanium alloy components of the commercially available Howmedica Osteonics® Xia™ Spinal System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical spine, fifth lumbar-first sacral (L5-S1) vertebral joint, lumbar and sacral spine, L3 to S1 or the ilium, thoracic, lumbar and sacral spine, thoracic to sacral spine, thoracic and lumbar spine.
Indicated Patient Age Range
skeletally mature patients
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)
Mechanical testing demonstrates that the device will meet the mechanical functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Xia™ Spinal System L-Connector
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
NOV 1 6 1999
Xia™ Spinal System C-C Adaptor
1992792
510(k) Premarket Notification
510k Summary
| Device: | Xia™ Spinal System C-C Adaptor |
|---|---|
| Common name: | Spinal Fixation Device |
| Classification Name: | Spinal Interlaminal Fixation Orthosis, 21 CFR 888.3050 |
| Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060 | |
| Pedicle Screw Spinal System, 21 CFR 888.7070 | |
| Regulatory Class: | Class II |
| Product Code: | 87 KWP, 87KWQ, 87MNH AND 87MNI |
| Contact Person: | Karen Ariemma, Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, New Jersey 07401-1677 | |
| phone (201) 760-8187 | |
| fax (201) 934-4368 |
The Xia™ Spinal System C-C Adaptor is a line extension to the Xia™ Spinal System. It consists of a C-C Adaptor with a set screw. The Xia™ Spinal System C-C Adaptor is a lateral connector. When used with a Xia™ Spinal System I-Connector, it allows for attachment of a hook to the longitudinal rod. The components are manufactured from titanium alloy.
The Xia™ Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia™ Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar-first sacral (L5-S1) vertebral joint which is fused; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screw fixation is limited to 1.3 to S1 or the ilium.
1
510(k) Premarket Notification
When used as a pedicle screw fixation system, the Xia™ Spinal System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (psuedoarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac fixation system, the Xia™ Spinal System is indicated for patients with degenerative disc disease of the thoracic, lumbar, which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, tumor, psuedoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia™ Spinal System is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia™ Spinal System is indicated for use in the thoracic and lumbar spine.
The substantial equivalence of this device is based on an equivalence in intended use, materials, design and operational principles to the predicate Xia™ Spinal System L-Connector. Mechanical testing demonstrates that the device will meet the mechanical functional requirements.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract design of three human profiles facing right, with three curved lines above them, resembling a stylized bird or wing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1999
Ms. Elizabeth A. Staub Vice President, Quality Assurance, Regulatory Affairs, Clinical Research Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
K992792 Re: Howmedica Osteonics® XIA™ Spinal System Trade Name: Requlatory Class: II Product Codes: KWQ, KWP, MNH, and MNI Dated: August 17, 1999 Received: August 19, 1999
Dear Ms. Staub:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Elizabeth A. Staub
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation entifical "Hibbranding by 1015. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K 942 792
Device Name: Howmedica Osteonics® Xia™ Spinal System C-C Adaptor
The subject components, Howmedica Osteonics® Xia™ Spinal System C-C Adaptor, are singleuse devices which are sold non-sterile and are intended for use only with the other titanium alloy components of the commercially available Howmedica Osteonics® Xia™ Spinal System.
The Xia™ Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia™ Spinal System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar-first sacral (L5-S1) vertebral joint which is fused; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screw fixation is limited to L3 to S1 or the ilium.
When used as a pedicle screw fixation system, the Xia™ Spinal System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (psuedoarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac fixation system, the Xia™ Spinal System is indicated for patients with degenerative disc disease of the thoracic. lumbar, which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, tumor, psuedoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia™ Spinal System is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia™ Spinal System is indicated for use in the thoracic and lumbar spine.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X OR Over-The-Counter Us
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992792