K011556 · Aesculap, Inc. · KWQ · Nov 16, 2001 · Orthopedic
Device Facts
Record ID
K011556
Device Name
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
Applicant
Aesculap, Inc.
Product Code
KWQ · Orthopedic
Decision Date
Nov 16, 2001
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3060
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
This anterolateral/anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T3-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral/anterior spine plate and rod system, the macs " HMA Anterior Spinal Stabilization System is indicated for patients with: - Degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - Spondylolisthesis - Spondylolysis - Fracture - Spinal stenosis - Deformities (i.e., scoliosis, kyphosis, lordosis, whether neuromuscular or related to deficient posterior elements) - Tumors (neoplastic disease) - Pseudarthrosis - Failed previous fusion surgery
Device Story
Anterior spinal stabilization system; consists of implantable metallic plates, rods, clamps, locking nuts, and HMA polyaxial/monoaxial screws. Used during anterior spinal fusion surgery to provide stabilization to thoracic and lumbar spine (T3-L5). Components form construct via screw fixation to anterolateral vertebral bodies. Operated by surgeons in clinical setting. Provides mechanical support to facilitate solid spinal fusion. Benefits patients by stabilizing spine in presence of degenerative disease, deformity, or trauma.
Clinical Evidence
Bench testing only. Fatigue testing of worst-case system configuration performed on titanium constructs. No clinical data provided.
Technological Characteristics
Constructs made of titanium. Components include plates, rods, clamps, locking nuts, and polyaxial/monoaxial screws. Conforms to applicable ASTM and ISO standards. Mechanical fixation system; no software or energy source.
Indications for Use
Indicated for patients with degenerative disk disease, spondylolisthesis, spondylolysis, fractures, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, pseudarthrosis, or failed previous fusion surgery requiring stabilization of the thoracic and lumbar spine (T3-L5).
Regulatory Classification
Identification
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
Predicate Devices
K-Centrum Anterior Spinal Fixation System (K990959, K002371)
{0}------------------------------------------------
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In Accordance with SMDA of 1990
NOV 1 6 2001
# MACS™ HMA Anterior Spinal Stabilization System
May 16, 2001
| COMPANY: | Aesculap ®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Millington, Regulatory Associate<br>800-258-1946 (phone)<br>610-231-3713 (fax)<br>lisa.millington@aesculap.com (email) |
| TRADE NAME: | MACSTL HMA Anterior Spinal Stabilization System |
| COMMON NAME: | Anterior-Lateral Spinal Stabilization System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | KWQ |
| CLASSIFICATION: | 888.3060 – Spinal intervertebral body fixation orthosis |
| REVIEW PANEL: | Orthopedic and Rehabilitation Devices Panel |
# INTENDED USE
This anterolateral/anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T3-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral/anterior spine plate and rod system, the macs " HMA Anterior Spinal Stabilization System is indicated for patients with:
- . Degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis ●
- Spondylolysis
- . Fracture
- . Spinal stenosis
- Deformities (i.e., scoliosis, kyphosis, lordosis, whether . neuromuscular or related to deficient posterior elements)
- . Tumors (neoplastic disease)
- Pseudarthrosis
- Failed previous fusion surgery ●
{1}------------------------------------------------
# DEVICE DESCRIPTION
K011556
The MACS 1 HMA Anterior Spinal Stabilization System includes implantable metallic plates, rods, clamps, locking nuts and screws. The components are used in various combinations to form a construct for use during anterior spinal fusion surgery. The MACS" modular anterior construct system (K002824), which was cleared on May 8, 2001, consists of the twin screws, where as the MAC™ HMA Anterior Spinal Stabilization System consists of the HMA Polyaxial and Monoaxial Screws. Both of these systems are considered a part of each other. The stabilization plates, connection rods, fixation nut, locking screw, bone graft clamp and screw have been cleared under the MACS" modular anterior construct system (K002824).
### PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new MACST System conforms to applicable ASTM and ISO standards.
Fatigue testing of a "worst case" system configuration was conducted on samples of constructs made of titanium. A summary of this testing can be found in Section IV and the final reports are provided in Appendix I.
## SUBSTANTIAL EQUIVALENCE
MACS" HMA Anterior Spinal Stabilization System is substantially equivalent in their intended use, design, and basic operating principles to the following predicate devices:
K-Centrum Anterior Spinal Fixation System .
By The Spineology Group (#K990959 & K002371) The K-Centrum® - Anterior Spinal Fixation System is cleared for marketing. K-Centrum® is an anterior spinal construct made up of one rod connected to two cage-like vertebral body screws. This system was tested using ASTM F-1717-96 recommendations. Properties of stiffness. strength and fatique life were determined. The K-Centrum® is intended to be used for the surgical treatment of vertebral body fractures and tumors. Equivalence can be seen in the design, material composition, surgical technique, testing methodologies and intended use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized eagle with three curved lines representing its wings. The eagle is facing to the right. The eagle is surrounded by text that is arranged in a circular pattern. The text is difficult to read due to the image quality.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Ms. Lisa M. Millington Regulatory Associate Aesculap®. Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: KOI 1556 Trade/Device Name: MACST HMA Anterior Spinal Stabilization System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 24, 2001 Received: August 29, 2001
Dear Ms. Millington:
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 - Ms. Lisa M. Millington
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" (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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
**Sincerely yours,**
Colie M. Witter, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
# NOV 1 6 2001
# INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Kollste
Device Name: MACS™ HMA Anterior Spinal Stabilization System
Indication for Use:
This anterolateral / anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T3-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral / anterior spine plate and rod system, the macs " HMA Anterior Spinal Stabilization System is indicated for patients with:
- Degenerative disk disease defined as back pain of discogenic origin with ● degeneration of the disc confirmed by history and radiographic studies
- . Spondvlolisthesis
- . Spondvlolysis
- Fracture ●
- Spinal stenosis .
- Deformities (i.e., scoliosis, kyphosis, lordosis, whether neuromuscular or . related to deficient posterior elements)
- Tumors (neoplastic disease) ●
- Pseudarthrosis ●
- Failed previous fusion surgery .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (6
for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K011556
Prescription Use X or Over-the-Counter Use
(per 21 CFR 801.109) (Optional Format 3-10-98)
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.
