(79 days)
No
The summary describes a mechanical spinal implant system made of stainless steel, with no mention of software, algorithms, image processing, or AI/ML terms. The performance studies focus on mechanical strength and fatigue testing.
Yes
The device is described as "for temporary use and must be accompanied by the application of autogenous source bone graft only" to achieve "reduction and stabilization of grades III & IV spondylolisthesis". This indicates it is used for treatment, making it a therapeutic device.
No
The device is described as an implant system for surgical reduction and stabilization of spondylolisthesis, not for diagnosis.
No
The device description explicitly states it is made from surgical implant grade Stainless steel and describes physical components like screws.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant system (Webb-Morley Spine System) made of stainless steel, intended for the surgical stabilization of the spine. It is physically implanted into the body.
- Intended Use: The intended use is to reduce and stabilize spondylolisthesis through surgical implantation and bone grafting. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The device is a surgical implant, not a diagnostic tool used on biological samples.
N/A
Intended Use / Indications for Use
Reduction and stabilization of grades III & IV spondylolisthesis of the fifth lumbar to first sacral vertebral interspace only. The Webb-Morley Spine System is for temporary use and must be accompanied by the application of autogenous source bone graft only. Once solid fusion is achieved, surgical removal of the device system is recommended. Planned removal of the device occurs within one year of the original surgery in adults and within two years of reaching skeletal maturity for adolescents.
The use of the Webb-Morley Spine System as a pedicle screw system involves screw attachment at the sacrum, the L5 vertebral pedicles, the L4 vertebral pedicles and in isolated cases, the L3 vertebral pedicles. The inclusion of additional pedicular levels may sometimes be necessary in order to reduce the spondylolisthetic deformity at L5 - S1 and maintain adequate correction.
The Screws of this system are limited to L3-S1 or iliac screw fixation.
Severe Spondylolisthesis (Gr. III & IV) L5-S1,Degenerative Disc Disease,Fracture Dislocation
Product codes
87MNH, 87KWP
Device Description
The Webb-Morley Spine System is made from surgical implant grade Stainless Stainless steel of this type is steel meeting ASTM F-138-86 requirements. particularly well suited for use as surgical implants. In addition to excellent strength, fatigue and corrosion resistance characteristics, stainless steel has a very long history of use in the human body as an implant material.
The Webb-Morley Spine System has the same indications for use as the recently cleared TSRH® and PLSA systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fifth lumbar to first sacral vertebral interspace, sacrum, L5 vertebral pedicles, L4 vertebral pedicles, L3 vertebral pedicles
Indicated Patient Age Range
Adults, adolescents
Intended User / Care Setting
surgeons fully experienced in the use of such implants and the required specialized spinal surgery techniques.
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)
Device and system testing consisted of static testing and comparison fatigue testing against the TSRH® system. The results of both modes of testing revealed that the Webb-Morley Spine System is suitable for the cleared indications and the anticipated physiologic loads imposed on the system. Comparison test values for the Webb-Morley system and the TSRH® system implants are equivalent.
Static testing showed that the Webb-Morley Spine System has sufficient strength to perform in a functionally equivalent manner to the comparison device systems. The Webb-Morley Spine System demonstrates excellent fatigue and strength characteristics. Based on the testing, the Webb-Morley Spine System is equal or superior in performance to the TSRH® Spine System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 1 8 1996
Summary of Safety and Effectiveness Information (releasable upon request only)
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name/Contact
- Electro-Biology, Inc. Company: 6 Upper Pond Road Parsippany, NJ 07054-1079
- Ms. Sharon A. Starowicz Contact: Director, Regulatory Affairs Electro-Biology, Inc. 6 Upper Pond Road Parsippany, NJ 07054-1079 (201) 299-9022 (201) 299-0906 - Fax
Establishment Registration Number: 2242816
Device Name:
Trade Name:
Webb-Morley Spine System
Common Name(s): Pedicular Spine System
Classification Spondylolisthesis Spinal Fixation Device System Name(s):
Classification Code(s): 87MNH
Substantially Equivalent Device(s)
- TSRH® Posterior Spine System 1. Sofamor/Danek K932029
-
- Posterior Lumbar Sacral Attachment (PLSA) Spine System Advanced Spine Fixation Systems K945064
1
Device Description
Background. This document summarizes safety and effectiveness information about the Webb-Morley Spine System. The full information is contained in the 510(k) Premarket Notification submitted to FDA in support of EBIs' request for a finding of Substantial Equivalence.
The Webb-Morley Spine System is made from surgical implant grade Stainless Stainless steel of this type is steel meeting ASTM F-138-86 requirements. particularly well suited for use as surgical implants. In addition to excellent strength, fatigue and corrosion resistance characteristics, stainless steel has a very long history of use in the human body as an implant material.
The Webb-Morley Spine System has the same indications for use as the recently cleared TSRH® and PLSA systems. This indication for use is:
Reduction and stabilization of grades III & IV spondylolisthesis of the fifth lumbar to first sacral vertebral interspace only. The Webb-Morley Spine System is for temporary use and must be accompanied by the application of autogenous source bone graft only. Once solid fusion is achieved, surgical removal of the device system is recommended. Planned removal of the device occurs within one year of the original surgery in adults and within two years of reaching skeletal maturity for adolescents.
The use of the Webb-Morley Spine System as a pedicle screw system involves screw attachment at the sacrum, the L5 vertebral pedicles, the L4 vertebral pedicles and in isolated cases, the L3 vertebral pedicles. The inclusion of additional pedicular levels may sometimes be necessary in order to reduce the spondylolisthetic deformity at L5 - S1 and maintain adequate correction.
The Screws of this system are limited to L3-S1 or iliac screw fixation.
Contraindications. The existence of the following diseases or medical conditions generally excludes candidates from treatment with this type of spinal implant system.
- A. Patients with spinal infection or inflammation
- B. Morbid obesity
- C. Mental illness, alcoholism, drug abuse
- D. Pregnancy
- E. Metal sensitivity or foreign body sensitivity
- F. Patients with inadequate tissue coverage at the operative site
- G. Open wounds local to the operative area
As an additional precaution, the Webb-Morley Spine System should only be implanted by surgeons fully experienced in the use of such implants and the required specialized spinal surgery techniques. Instructional course demonstrations and/or bio-skills workshops demonstrating the use of the Webb-Morley Spine
2
System implants may be offered following a finding of substantial equivalence by the FDA.
A comprehensive list of indications, contraindications, adverse effects, warnings and precautions may be reviewed in the package insert supplied with the system. Only the package insert is to be considered definitive or accurate in terms of system applications, uses or restrictions.
Packaging:
All packaging is commercially available industry standard items and is sufficient in design and material quality to provide durable identification and protection from physical damage during transportation and storage. The type of packaging used is essentially the same as that used for the TSRH® and the PLSA systems.
Sterilization/Re-sterilization:
All instruments and implants are supplied Non-Sterile. Device packages clearly indicate the sterility status of the contained component. Steam autoclave sterilization is the only processing method recommended for the Webb-Morley Spine System. A cleaning and validated sterilization process recommendation is located in the product package insert. Please obtain and review the package insert before using the system. The recommended sterilization method, time and temperature for the implants is gravity steam sterilization for 45 minutes at 1219 C (250° F).
The Sterility Assurance Level (SAL) of the recommended sterilization cycle is 10° (SAL 10°). Validation of the recommended cycle has been conducted by qualified The validation method used is known as the overkill commercial laboratories. method.
Summary of Physical Testing:
Device and system testing consisted of static testing and comparison fatigue testing against the TSRH® system. The results of both modes of testing revealed that the Webb-Morley Spine System is suitable for the cleared indications and the anticipated physiologic loads imposed on the system. Comparison test values for the Webb-Morley system and the TSRH® system implants are equivalent.
Static testing showed that the Webb-Morley Spine System has sufficient strength to perform in a functionally equivalent manner to the comparison device systems. The Webb-Morley Spine System demonstrates excellent fatigue and strength characteristics. Based on the testing, the Webb-Morley Spine System is equal or superior in performance to the TSRH® Spine System.
3
Equivalence:
The table concluding this section summarizes available information for the comparison devices. The Substantially Equivalent devices and the Webb-Morley Spine System are all posterior surgical approach systems. All are used to treat similar or the same conditions. All have essentially the same cautions and contraindications for use. All have the same labeling warnings imposed by FDA. All are basic spinal rod, transverse interconnection and pedicle/sacral bone screw posterior spinal systems.
Design of the rods and pedicle screws of the Webb-Morley Spine System do not represent a significant departure from long established designs in terms of safety or effectiveness. The Webb-Morley Spine System utilizes identical implant materials (stainless steel) meeting BS, ISO and ASTM standards.
Conclusion:
The design features of the Webb-Morley Spine System are equivalent to those offered by the TSRH® and PLSA systems. Components of the comparable systems are all made from the same or equivalent implant grade materials. Device testing, engineering review, and comparison of the system components to the referenced devices demonstrates their functional engineering equivalence .
The Webb-Morley Spine System is currently distributed in the US, Europe and elsewhere in the world. Performance of the Webb-Morley Spine System for severe spondylolisthesis of L5/S1 is expected to be comparable to the TSRH® and PLSA devices.
Since the indications for use, system limitations and surgical techniques are well established and understood, spinal implant systems using such basic design elements may reasonably be expected to perform predictably. EBI uses current Good Manufacturing Practice regulations, in-house SOPs and appropriate ASTM standards to assure that the Webb-Morley Spine System performs predictably and is Substantially Equivalent. A summary feature comparison table follows.
4
| FEATURE | Webb-Morley® | TSRH® System | PLSA Spinal
System | Substantial
Equivalence |
|------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------|----------------------------|
| Surgical
Approach: | Posterior | Posterior | Posterior | Yes |
| Materials: | 316 LVM stainless steel | Titanium Alloy & 316
LVM Stainless Steel | Titanium Alloy | Yes |
| Indications for
Use: | Severe Spondylolisthesis (Gr.
III & IV) L5-S1,
Degenerative Disc Disease,
Fracture Dislocation | Same