When used as a Vertebral Body Replacement Device: The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft. When used as an Intervertebral Body Fusion System: The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.
Device Story
CeSpace XP is a cervical intervertebral body fusion device implanted into the vertebral space to improve stability and support fusion. Components are PEEK implants with a titanium layer and vacuum plasma spray coating (Plasmapore). Tantalum markers are included for radiographic visualization. The device is used by surgeons in clinical settings to restore vertebral height and achieve decompression. It is intended for use with supplemental spinal fixation (e.g., Aesculap S4 System) and autogenous bone graft. By providing structural support and a surface for fusion, the device aims to alleviate discogenic pain and stabilize the spinal segment.
Clinical Evidence
Bench testing only. Testing included static and dynamic torsion, axial compression, and shear resistance per ASTM F2077; subsidence per ASTM F2267; and coating characterization per ASTM F1854, F1147, F1044, F1160, and F1978.
Technological Characteristics
Materials: PEEK, titanium layer, vacuum plasma spray coating (Plasmapore per ISO 5832-3), Tantalum markers (ASTM F560). Form factor: Circular with flattened sides, various sizes. Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None.
Indications for Use
Indicated for skeletally mature patients with degenerative disc disease (DDD) at one level (C3-C7) or for thoracolumbar (T1-L5) vertebral body replacement due to tumor or trauma. Requires 6 weeks of prior non-operative treatment.
Regulatory Classification
Identification
An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.
Special Controls
*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
*Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Predicate Devices
Aesculap CeSpace PEEK VBR and Intervertebral Body Fusion Systems (K083311)
Submission Summary (Full Text)
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# APR 1 5 2013
CeSpace PEEK Intervertebral Body Fusion System (Plasmapore® Coated)
K123909
Page 1 of 3
#### 510(k) SUMMARY (as required by 21 CFR 807.92) B.
## Aesculap® Implant Systems(AIS) - CeSpace XP Intervertebral Body Fusion System
#### December 18, 2012
| COMPANY: | Aesculap® Implant Systems (AIS), LLC.<br>3773 Corporate Parkway |
|----------|--------------------------------------------------------------------------|
| | Center Valley, PA 18034<br>Establishment Registration Number: 300567331- |
Lisa M. Boyle, Sr. Regulatory Affairs Specialist CONTACT: 610-984-9274 (phone) 610-791-6882 (fax) lisa.boyle@aesculap.com
| TRADE NAME: | AIS CeSpace XP Intervertebral Body Fusion System |
|----------------------|--------------------------------------------------|
| COMMON NAME: | Intervertebral Body Fusion Device |
| CLASSIFICATION NAME: | Orthosis, Spinal Intervertebral Fusion |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | ODP |
| REVIEW PANEL: | Orthopedics |
### INDICATIONS FOR USE
# When used as a Vertebral Body Replacement Device:
The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebrail body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.
## When used as an Intervertebral Body Fusion System:
The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion erodial in Shape Min Hattoned elessed telefally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.
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CeSpace PEEK Intervertebral Body Fusion System (Plasmapore® Coated) K123909
> Page 2 of ತಿ
## DEVICE DESCRIPTION
The Aesculap CeSpace XP Intervertebral Body Fusion System is a cervical intervertebral I no fusiondevice that is implanted into the vertebral body space to improve stability of bour fusional hile supporting fusion. Components are offered in a variety of sizes to meet the requirements of the individual patient anatomy. Components are manufactured from the requirements of the Inalifical P026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have Tantalum markers per ASTM F-560.
# TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The components of the CeSpace XP Intervertebral Body Fusion System are offered in the same range of shapes and sizes as the predicate device. The material used for the the same Tango of Systems device is the same as that used to manufacture the predicate devices. The only difference between the predicate device and the subject produce is the titanium layer and a vacuum plasma spray coating (Plasmapore®).
## PERFORMANCE DATA
As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the AIS SIBD XP Spinal System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic torsion per ASTM F2077 .
- Static and dynamic axial compression per ASTM F2077 .
- Shear resistance evaluation .
- . Subsidence per ASTM F2267
In addition to FDA's Spine Guidance, Aesculap has also completed non-clinical testing in addition to in the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." The following tests were performed:
- Microstructure of the coating per ASTM F1854 .
- Static Tensile Strength per ASTM F1147 .
- Static Shear Strength per ASTM F1044 .
- Shear Fatigue Test per ASTM F1160 .
- · Abrasion Resistance per ASTM F1978
The results of these tests showed that the CeSpace XP Spinal Implant System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
## SUBSTANTIAL EQUIVALENCE
AIS believes that the Cespace XP Intervertebral Body Fusion System is substantially All believes that the Ocepace Al " in the Aesculap CeSpace PÉEK VBR and Intervertebral Body
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K123909 Page 3 of 3
Fusion Systems (K083311). The Plasmapore® coating has been used and cloared in a number of legally marketed product lines manufactured by Aesculap (hip, knee, and spinal implants) for many years.
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "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 curved lines representing its wings or body.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
### April 15, 2013
Aesculap Implant Systems, Incorporated % Ms. Lisa Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K123909
Trade/Device Name: Aesculap® Implant Systems (AIS) - CeSpace XP Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 13, 2013 Received: March 14, 2013
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
{4}------------------------------------------------
### Page 2 - Ms. Lisa Boyle
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/7 description: The image shows the name "Erin I. Keith" in a stylized font. The first name, "Erin," is written in a standard, bold typeface. The middle initial, "I.," and the last name, "Keith," are rendered in a more decorative, outlined font, giving the overall name a unique and visually distinct appearance. The design suggests a logo or personal branding element.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CeSpace PEEK Intervertebral Body Fusion System (Plasmapore® Coated)
Page 1 of 1
#### INDICATIONS FOR USE STATEMENT A.
510(k) Number:_ K123909
## Device Name: Aesculap® Implant Systems (AIS) – CeSpace XP Intervertebral Body Fusion System
#### Indications for Use:
### When used as a Vertebral Body Replacement Device:
The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral or the upinal one and the Intent System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.
# When used as an Intervertebral Body Fusion System:
The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion orrocedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 The Aesculap PEEK Spinal Implant System is also intended for use with System. autogenous bone graft.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.
Prescription Use
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
> Anton E. Dmitriev. PhD Division of Orthopedic Devices
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.
