(28 days)
Not Found
No
The summary describes a spinal rod and its intended uses, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is a spinal rod intended for fixation in the spine to treat various conditions like degenerative spondylolisthesis, fractures, scoliosis, and failed fusions, all of which aim to alleviate symptoms or correct anatomical issues.
No
Explanation: The MONARCH Spine System, specifically the spinal rod described, is indicated for fixation in various spinal conditions and is intended to be implanted. It is a treatment device, not a device used to identify or diagnose a condition.
No
The device description explicitly states it is a "Commercially Pure Titanium Spinal Rod," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant system used for spinal fixation in various conditions like spondylolisthesis, fracture, scoliosis, etc. This is a therapeutic device used in vivo (within the body) to provide structural support.
- Device Description: The device is described as a spinal rod, which is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is implanted within the body for structural support.
N/A
Intended Use / Indications for Use
The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.
The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI, KWP
Device Description
The MONARCH Commercially Pure Titanium Spinal Rod is a 6.35mm diameter rod available in various lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, sacral spine, L5-S1, T1 to the ilium/sacrum
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)
Performance data were submitted to characterize the MONARCH Commercially Pure Titanium Spinal Rod.
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.
MONARCH Spine System Spinal Rod (K010576)
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
attained. Levels of attachment for this indication
range from L3 to the sacrum.
MAY 0 8 2002
IX. 510(k) Summary
SUBMITTER:
| | 325 Paramount Drive
Raynham, MA 02767 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lisa A. Gilman |
| DATE PREPARED: | March 29, 2002 |
| | CLASSIFICATION NAME: Appliance, Fixation, Spinal Interlaminal
Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | MONARCH SPINE SYSTEM COMMERCIALLY
PURE TITANIUM SPINAL ROD |
| PREDICATE DEVICES: | MONARCH Spine System Spinal Rod (K010576) |
| DEVICE DESCRIPTION: | The MONARCH Commercially Pure Titanium Spinal
Rod is a 6.35mm diameter rod available in various
lengths. |
| INTENDED USE: | The MONARCH Spine System when used with
pedicle screws is indicated for degenerative
spodylolisthesis with objective evidence of neurologic
impairment, fracture, dislocation, scoliosis, kyphosis,
spinal tumor, and failed previous fusion
(pseudarthrosis). Levels of fixation are for the
thoracic, lumbar and sacral spine. |
| | The MONARCH Spine System is also indicated for
pedicle screw fixation for Grade 3 and 4
spondylolisthesis at L5-S1, in skeletally mature
patients, utilizing autologous bone graft, having the
device fixed or attached to the lumbar or sacral spine
and intended to be removed after solid fusion is |
DePuy AcroMed, Inc.
1
The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion.
1021148
MATERIALS:
Manufactured from Grade 3 commercially pure (cp) titanium conforming to ASTM F-67.
PERFORMANCE DATA:
Performance data were submitted to characterize the MONARCH Commercially Pure Titanium Spinal Rod.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 8 2002
Mr. Frank Maas Director, Regulatory Affairs DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K021148
Trade/Device Name: MONARCH Spinal System Commercially Pure Titanium Spinal Rod
Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI, KWP Dated: April 5, 2002 Received: April 10, 2002
Dear Mr. Maas:
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 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 (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. A 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 regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. 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 - Mr. Frank Maas
This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and in you of substantial equivalence of your device to a legally marketed nouticate 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 11 you desire specific arrivitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in The areguestions on the promotion and advertising of your device, (301) 594-1659. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. AN Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| III. | Indications for Use |
|---|---|
| ------ | --------------------- |
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
page 1 of 1
MONARCH Spine System Spinal Rod Device Name:
Indications For Use:
The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing Shado o and '1 spenay.com the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.
The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter Use: Prescription Use: (Per 21 CFR 801.109)
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K021148