K983583 · Depuy, Inc. · KWP · Dec 3, 1998 · Orthopedic
Device Facts
Record ID
K983583
Device Name
DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS
Applicant
Depuy, Inc.
Product Code
KWP · Orthopedic
Decision Date
Dec 3, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3050
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
When used as a posterior, noncervical screw fixation system or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic; back pain with degeneration of the disc confirmed by patient history and radiographic studies). When used as a pedicle screw fixation system of the noncervical spine in skeletally matrue patients, the MOSS Miami System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The MOSS Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
Device Story
MOSS Miami Spinal System is a rod and screw spinal instrumentation set; components include longitudinal rods, monoaxial/polyaxial/reduction screws, hooks, transverse/axial connectors, washers, and sacral extenders. Available in stainless steel or titanium. Used by surgeons in clinical settings to treat spinal pathologies including scoliosis, kyphosis, lordosis, fractures, tumors, and degenerative disc disease. System provides mechanical stabilization of the spine to facilitate fusion. Components are implanted to provide structural support; intended for removal after solid fusion mass development in specific severe spondylolisthesis cases.
Clinical Evidence
No clinical data provided; substantial equivalence is based on design and material identity to previously cleared predicate devices.
Technological Characteristics
System components include longitudinal rods, monoaxial/polyaxial/reduction screws, hooks, transverse/axial connectors, washers, and sacral extenders. Materials: Stainless steel or titanium. Mechanical fixation system; no software or electronic components.
Indications for Use
Indicated for skeletally mature patients requiring noncervical spinal fixation for degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion, or severe spondylolisthesis (Grades 3-4) at L5-S1.
Regulatory Classification
Identification
A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
Predicate Devices
DePuy Motech MOSS Miami Spinal System (for posterior use)
DePuy Motech MOSS Miami Spinal System -Pedicle Fixation
DePuy Motech MOSS Miami Spinal System anterior indications
DePuy Motech MOSS Miami 4.0 mm Rod Spinal Subsystem
DePuy Motech Universal Spinal System and Transverse Rod Stabilizer
Biedermann Motech MOSS Miami Spinal System, 6.0mm Rod Subsystem
DePuy Motech Titanium MOSS Miami Spinal System
DePuy Motech MOSS Miami Spinal System Ratchet Rods
DePuy Motech MOSS Miami Titanium Sacral Extenders
Submission Summary (Full Text)
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K983583
Image /page/0/Picture/27 description: The image shows the logo for DePuy AcroMed. The logo consists of a black circle on the left, followed by the text "DePuyAcroMed" in a stylized font. The letters are connected and have a slightly rounded appearance. To the right of the text, there is a small "TM" symbol, indicating a trademark.
DEC 3 1998
13 Carnenie Ave
510(k) SUMMARY OF SAFETY AND EFFF
Lynnette Whitaker
Tel: +1 (216) 432 6998
Fax: +1 (216) 432 6999
NAME OF FIRM:
DePuy Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
510(K) CONTACT:
TRADE NAME:
COMMON NAME:
CLASSIFICATION:
888.3050 Spinal interlaminal fixation orthosis 888.3070 Pedicle screw spinal system 888.3060 Spinal intervertebral body fixation orthosis
Manager, Clinical and Regulatory Affairs
Rod and screw spinal instrumentation
DePuy AcroMed MOSS Miami Spinal System
DEVICE PRODUCT CODE:
Product code: 87KWP 87MNH 87MNI 87KWQ
SUBSTAINTIALLY EQUIVALENT DEVICES: DePuy Motech MOSS Miami Spinal System (for posterior use)
DePuy Motech MOSS Miami Spinal System -Pedicle Fixation
DePuy Motech MOSS Miami Spinal System anterior indications
DePuy Motech MOSS Miami 4.0 mm Rod Spinal Subsystem
DePuy Motech Universal Spinal System and Transverse Rod Stabilizer
Biedermann Motech MOSS Miami Spinal System, 6.0mm Rod Subsystem
DePuy Motech Titanium MOSS Miami Spinal System
DePuy Motech MOSS Miami Spinal System Ratchet Rods
DePuy Motech MOSS Miami Titanium Sacral Extenders
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## DEVICE DESCRIPTION AND INTENDED USE:
The MOSS MIAMI System is available in either Stainless Steel or Titanium. The following components are available in Stainless Steel: longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial connectors, staple washers and sacral extenders. The following components are available in Titanium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.
When used as a posterior, noncervical screw fixation system or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic; back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally matrue patients, the MOSS Miami System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The MOSS Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
## BASIS OF SUBSTANTIAL EQUIVALENCE:
The components of the MOSS Miami Spinal System are identical to the components of the other MOSS Miami Spinal Systems which have been cleared by FDA for certain anterior and posterior uses and for pedicle fixation use indications.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 3 1998
Ms. Lynnette Whitaker Manager, Clinical and Regulatory Affairs DePuy Motech AcroMed, Inc. 3303 Carnegie Avenue Cleveland, Ohio 44115
Re: K983583 MOSS® Miami Spinal System - expanded uses Regulatory Class: II Product Codes: MNI, KWP, KWQ, and MNH Dated: October 9, 1998 Received: October 13, 1998
Dear Ms. Whitaker:
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 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). 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
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Page 2 - Ms. Lynnette Whitaker
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 premarket notification" (21CFR 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Page 2 - Ms. Lynnette Whitaker
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 premarket notification" (21CFR 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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.
6. Collections
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.
How do you save a set of selected devices for later use?
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
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
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.
