K130699 · K2m, Inc. · MAX · May 30, 2013 · Orthopedic
Device Facts
Record ID
K130699
Device Name
ALEUTIAN SPINAL SYSTEM
Applicant
K2m, Inc.
Product Code
MAX · Orthopedic
Decision Date
May 30, 2013
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3080
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
Device Story
Aleutian Spinal System comprises hollow, horseshoe-shaped intervertebral body fusion (IBF) and vertebral body replacement (VBR) implants. Implants feature machined teeth for vertebral endplate engagement. Used in spinal fusion or partial vertebrectomy procedures to provide stabilization, restore disc height, and achieve anterior decompression. Operated by surgeons in clinical/OR settings. Implants require supplemental internal fixation (pedicle screws, hooks, or plates). Benefits include restoration of spinal column biomechanical integrity and support for fusion. Device design matches patient anatomy via varied sizes/heights.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing (static compression, static torsion, dynamic compression per ASTM F2077) and Finite Element Analysis.
Technological Characteristics
Materials: PEEK Optima LT1 (ASTM F2026) and Tantalum (ASTM F560). Form factor: Hollow/horseshoe-shaped spacers with machined teeth. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.
Indications for Use
Indicated for skeletally mature patients requiring spinal fusion or vertebral body replacement. Cervical: C2-T1, one level, discogenic neck pain, 6 weeks failed non-operative treatment. Lumbar: L2-S1, one or two levels, degenerative disc disease with up to Grade 1 spondylolisthesis, 6 months failed non-operative treatment. Thoracolumbar: T1-L5, partial vertebrectomy for tumors or trauma/fracture. Requires supplemental internal fixation.
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.
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This safety and effectiveness summary for the Aleutian 18F System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
1. Submitter : K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person : Nancy Giezen K2M, Inc. Telephone: 703-777-3155
Date Prepared: March 29, 2013
| 2. Tradename: | Aleutian IBF System |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, lumbar (Product Code: MAX)<br>Intervertebral Fusion Device with Bone Graft, cervical (Product Code: ODP)<br>Spinal Vertebral Body Replacement Device (Product Code: MQP) |
| Regulation Number: | 888.3080, 888.3060 |
| Device Class: | Class II |
## 3. Description of the device:
The Aleutian Spinal System consists of a hollow tube or horseshoe-shaped structures manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
Materials: The implants are manufactured from PEEK Optima LT1 per ASTM F2026. Tantalum beads/ rods are to be made of Grade UNS R05200, UNS R05400 according to ASTM F560.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.
The purpose of this submission is to incorporate additional lumbar implants into the system.
## 4. Intended Use:
.
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
MAY 3 0 2013
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For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
## 5. Predicate or legally marketed devices which are substantially equivalent:
Documentation was provided which demonstrated that the subject Aleutian Spinal System components are substantially equivalent to devices previously cleared in K2M's Aleutian Spinal System (K082698, 2 K101302, K103169, K110843, K113138) and to the Zimmer InFix device (K031672).
## 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
Previously cleared Aleutian spacers were tested in static compression, static torsion and dynamic compression per ASTM F2077. The proposed spacers were determined not to represent a new worst case as determined by Finite Element Analysis and are considered substantially equivalent to the predicates referenced.
## 7. Conclusion:
There are no significant differences between the Aleutian Spinal System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized caduceus with a human figure in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion. The emblem is black, and the text is also black.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2013
K2M, Incorporated % Ms. Nancy Giezen Manager Regulatory Affairs 751 Miller Drive Southeast Leesburg, Virginia 20175
Re: K130699
Trade/Device Name: Aleutian Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 30, 2013 Received: April 30, 2013
Dear Ms. Giezen:
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, Drugand 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
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# Page 2 -- Ms. Nancy Giezen
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
For
Sincerely yours,
ErinHDKeith
Mark N. Melkerson
-Director-Division of Orthopedic Devices_ Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# 510(k) Number (if known): K130699
#### Device Name : Aleutian Spinal System
## Indications For Use :
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of turnors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
Prescription use X
OR
Over-the-counter use ( PER 21 CFR 801.109)
# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
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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.
