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.
Device Story
Pedicular spine system for posterior surgical stabilization of L5-S1 spondylolisthesis; utilizes stainless steel rods, pedicle/sacral screws, and hooks to provide mechanical fixation; requires autogenous bone graft for fusion; temporary implant intended for surgical removal after fusion; implanted by experienced spinal surgeons in OR setting; provides structural support to reduce deformity and maintain correction; benefits patient by facilitating spinal fusion and stabilizing vertebral segments.
Clinical Evidence
Bench testing only. Static and fatigue testing compared the Webb-Morley system against the TSRH system. Results indicated sufficient strength to withstand anticipated physiologic loads and functional equivalence to predicate devices.
Technological Characteristics
Constructed from surgical implant grade stainless steel (ASTM F-138-86, ISO-5832-1, BS-7252). System includes rods (4.0mm round, 4.0mm x 6.0mm oval), pedicular/sacral screws (5.5mm, 6.5mm, 7.5mm), and hooks. Posterior surgical approach. Non-sterile; requires steam autoclave sterilization (gravity cycle, 121°C for 45 minutes, SAL 10^6).
Indications for Use
Indicated for patients with grade III or IV spondylolisthesis at the L5-S1 vertebral interspace requiring reduction and stabilization. Contraindicated in patients with spinal infection/inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal/foreign body sensitivity, inadequate tissue coverage, or local open wounds.
Regulatory Classification
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.
Special Controls
*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.
Posterior Lumbar Sacral Attachment (PLSA) Spine System (K945064)
Submission Summary (Full Text)
{0}
K960451
APR 18 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
**Company:** Electro-Biology, Inc.
6 Upper Pond Road
Parsippany, NJ 07054-1079
**Contact:** Ms. Sharon A. Starowicz
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 Name(s):** Spondylolisthesis Spinal Fixation Device System
**Classification Code(s):** 87MNH
## Substantially Equivalent Device(s)
1. TSRH® Posterior Spine System
Sofamor/Danek
K932029
2. Posterior Lumbar Sacral Attachment (PLSA) Spine System
Advanced Spine Fixation Systems
K945064
david/ebi/webb3.doc
6
{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 steel meeting ASTM F-138-86 requirements. Stainless steel of this type is 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
david/ebi/webb3.doc
{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 121° C (250° F).
The Sterility Assurance Level (SAL) of the recommended sterilization cycle is 10⁶ (SAL 10⁶). Validation of the recommended cycle has been conducted by qualified commercial laboratories. The validation method used is known as the overkill 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.
david/ebi/webb3.doc
{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.
david/ebi/webb3.doc
{4}
# FEATURE COMPARISON TABLE
| 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< | Same | Yes |
| Clinical Experience: | European | US & European | US & European | Yes |
| Hooks: | Laminar hooks, pedicle hooks, transverse process hooks | Same Types | Same Types | Yes |
| Rods | 4.0mm round & 4.0mm X 6.0mm oval | 1/4" & 3/16" rods | 1/4" & 3/16" | Yes |
| Pedicular & Sacral Screws: | Cancellous threads 5.5mm, 6.5mm & 7.5mm | Same | Same | Yes |
| Meets BS, ISO & ASTM Standards: | BS-7252, ISO-5832-1 & ASTM F-138-86 | F-138-86, Gr. 2 & F-136-92 | F-136-92 | Yes |
| Transverse Interconnection: | Yes | Yes | Yes | Yes |
| Sterilization Method: | Steam Sterilization per HIMA/AORN | Same | Same | Yes |
| Manufacturer: | Electro-Biology, Inc. | Sofamor/Danek | Advanced Spine Fixation Systems, Inc. | Yes |
| Classification Code: | 87KWP & 87MNH | 87KWP& 87MNH | 87KWP & 87MNH | Yes |
| K-Number | NA | K932029 | K945064 | NA |
david/ebi/webb3.doc
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
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With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
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Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
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What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
