K014267 · Medtronic Sofamor Danek, Inc. · KWP · Jan 25, 2002 · Orthopedic
Device Facts
Record ID
K014267
Device Name
BUTTERFLY PLATE FIXATION SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
Product Code
KWP · Orthopedic
Decision Date
Jan 25, 2002
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3050
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The BUTTERFLYT™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1. Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 2. Pseudoarthrosis. 3. Spondylolysis. 4. Spondylolisthesis. 5. Fracture. 6. Neoplastic disease. 7. Unsuccessful previous fusion surgery. 8. Lordotic deformities of the spine. 9. Idiopathic thoracolumbar or lumbar scoliosis. 10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele. 11. Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.
Device Story
BUTTERFLY PLATE Fixation System provides temporary stabilization of thoracic and lumbar spine (T1-L5) via anterolateral intervertebral body fixation. System comprises titanium alloy plates, screws, bolts, and nuts; construct is tailor-made for individual patient anatomy. Surgeon attaches plate to vertebral bodies using rigid bolts or variable-angle screws on one side of spine. Device maintains alignment until solid spinal fusion occurs. Used in clinical settings by surgeons; output is mechanical stabilization of spinal segments. Benefits include correction of deformities and stabilization of degenerative or traumatic spinal conditions.
Clinical Evidence
No clinical data provided. Substantial equivalence based on risk analysis and bench testing.
Technological Characteristics
Materials: Titanium alloy (Ti-6Al-4V) per ASTM F136 or ISO 5832-3. Components: Plates, screws, bolts, nuts. Configuration: Anterolateral intervertebral body fixation. Connectivity: None. Sterilization: Not specified.
Indications for Use
Indicated for patients requiring temporary spinal stabilization during fusion from T1 to L5. Conditions include DDD, pseudoarthrosis, spondylolysis, spondylolisthesis, fractures, neoplastic disease, failed prior fusion, lordotic deformities, idiopathic thoracolumbar/lumbar scoliosis, deformities with deficient posterior elements (laminectomy, spina bifida, myelomeningocele), and neuromuscular deformity with pelvic obliquity. Contraindicated for posterior element (pedicle) attachment.
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.
Sofamor Danek Z-Plate Anterior Fixation System (K922543)
Submission Summary (Full Text)
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## Medtronic Sofamor Danek BUTTERFLY PLATE Fixation System 510(k) Summary December 2001
K014267
Page 1 of 2
| Submitter: | Medtronic Sofamor Danek<br>1800 Pyramid Place<br>Memphis, TN 38132 | JAN 2 5 2002 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Richard Treharne | |
| Trade Name: | BUTTERFLY PLATE Fixation System | |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis, Class II | |
| Predicate Device(s): | The BUTTERFLY PLATE Fixation System is substantially equivalent to itself, the BUTTERFLY PLATE Fixation System, which was cleared in K010632 on May 31, 2001 and the Sofamor Danek Z-Plate Anterior Fixation System, which was cleared on May 19, 1993. | |
| Device Description: | The BUTTERFLY PLATE Fixation System construct consists of a plate fitted to match the antero-lateral vertebral bodies of the thoracic and lumbar spine. The plate is fastened to the bodies by either rigid bolts or variable-angle screws. The BUTTERFLY PLATE consists of a variety of shapes and sizes of plates, screws, bolts, and nuts, as well as ancillary products and instrument sets. The BUTTERFLY PLATE anterior implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The purpose of this submission is to add a cover plate to the system and to add a 6.5mm screw. The implant components are made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832- 3. Stainless steel and titanium implant components must not be used together in a construct. | |
| Intended Use: | The BUTTERFLYT™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. | |
| | When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include: | |
| 1. | Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). | |
| 2. | Pseudoarthrosis. | |
| 3. | Spondylolysis. | |
| 4. | Spondylolisthesis. | |
| 5. | Fracture. | |
| 6. | Neoplastic disease. | |
| 7. | Unsuccessful previous fusion surgery. | |
| 8. | Lordotic deformities of the spine. | |
| 9. | Idiopathic thoracolumbar or lumbar scoliosis. | |
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- 10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
- Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated 11. with pelvic obliquity.
Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.
Functionality & Safety Testing: A Risk Analysis was performed on the BUTTERFLY PLATE and was included in this submission. Conclusion: The subject components contained in this submission are substantially equivalent to the original BUTTERFLY PLATE Fixation System (K010632) and to the Sofamor Danek Z-Plate Anterior Fixation System (K922543).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines representing wings and a stylized head and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2002
Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K014267
Trade Name: Butterfly Plate Fixation System Regulation Number: 888.3050 and 888.3070 Regulatory Name: Spinal interlaminal fixation orthosis and Pedicle Screw System Regulatory Class: II Product Code: KWP and MNH Dated: December 21, 2001 Received: December 27, 2001
Dear Dr. Treharne:
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.
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.
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Page 2 - Richard W. Treharne, Ph.D.
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 additionally 607.10 for in This and includes on the promotion and advertising of your device, (201) 594-4639. Radinonary, con use at (301) 594-4639. Also, please note the regulation prease condor the Orifice or Somphanes et notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnees and its tollars. Inc. 100 million in (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely, Pam,
Mark McMullen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
## Device Name: BUTTERFLY PLATE FIXATION SYSTEM
The BUTTERFLY™ PLATE Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
1. Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- 2. Pseudoarthrosis.
- 3. Spondylolysis.
- 4. Spondylolisthesis.
- 5. Fracture.
- 6. Neoplastic disease.
- 7. Unsuccessful previous fusion surgery.
- 8. Lordotic deformities of the spine.
- 9. Idiopathic thoracolumbar or lumbar scoliosis.
10. Deformity (i.e., scoliosis, lordosis) and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity. Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic or lumbar spine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
## Concurrence of CDRH Office of Evaluation (ODE)
× Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)
OR
R
Over-the-counter Use
Mark N. Milken
Restorat
510(k) Number
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.
