BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
K081849 · Blackstone Medical, Inc. · OVD · Aug 28, 2008 · Orthopedic
Device Facts
Record ID
K081849
Device Name
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
Applicant
Blackstone Medical, Inc.
Product Code
OVD · Orthopedic
Decision Date
Aug 28, 2008
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3080
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
When used as an Intervertebral Body Fusion System: The PILLAR™ SA PEEK Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System. When used as a Partial Vertebral Body Replacement (VBR) System: The PILLAR™ SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The PILLAR™ SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).
Device Story
PILLAR SA PEEK Spacer System is an intervertebral body fusion and partial vertebral body replacement device. Implants are PEEK-OPTIMA LT1 (ASTM F-2026) with tantalum markers (ASTM F-560). System includes integrated anterior screw holes for titanium alloy screws and a titanium plate for screw securement. Superior/inferior surfaces feature ripple patterns for stability. Used in spinal surgery by physicians to restore biomechanical integrity, achieve decompression, and facilitate fusion. Device is implanted in the spine; provides structural support for bone graft (autograft/allograft). If fewer than four screws are used, supplemental internal fixation is required.
Clinical Evidence
No clinical data. Substantial equivalence is based on mechanical performance data and equivalence in configuration and indications for use.
Technological Characteristics
Materials: PEEK-OPTIMA LT1 (ASTM F-2026), tantalum markers (ASTM F-560), titanium alloy screws/plate. Form factor: Intervertebral spacer with integrated screw holes and ripple-patterned surfaces. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.
Indications for Use
Indicated for skeletally mature patients with degenerative disc disease (DDD) at 1-2 contiguous lumbar levels (L2-S1) with/without Grade 1 spondylolisthesis, or for partial vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumors or fractures. Requires 6 months non-operative treatment for DDD.
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
Blackstone Medical, Inc. Construx PL/TL Partial VBR Spacers (K060350)
Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109)
Medtronic Sofamor Danek, Intrepid Spinal System (K080083)
Submission Summary (Full Text)
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## le081849
Premarket Notification Special 510(k) Blackstone Medical, Inc. PILLAR SA PEEK Spacer System System Modification
#### 510(K) SUMMARY
AUG 2 8 2008
| Sponsor: | Blackstone Medical, Inc.<br>1211 Hamburg Turnpike<br>Suite 300<br>Wayne, NJ 07470 | AUG 28 2008 |
|-----------------------|-------------------------------------------------------------------------------------------------------------|-------------|
| Registration Number: | 3004606875 | |
| Contact Person: | Whitney G. Törning, Senior Director of Regulatory Affairs &<br>Quality Assurance | |
| Telephone Number: | 973.406.2838 | |
| Fax Number: | 973.406.2938 | |
| Email: | wtorning@blackstonemedical.com | |
| Submitter: | Martin G. Sprunck<br>Regulatory Affairs Manager | |
| Manufacturer: | Blackstone Medical, Inc.<br>90 Brookdale Drive<br>Springfield, MA 01104 | |
| Registration Number: | 1225457 | |
| Trade Name: | Blackstone PILLAR™ SA PEEK Spacer System | |
| Common Names: | Intervertebral Body Fusion Device<br>Spinal Partial Vertebral Body Replacement Device | |
| Classification | Class II | |
| Device Product Codes: | MAX - Intervertebral Fusion Device with Bone Graft, Lumba<br>MQP - Spinal Vertebral Body Replacement Device | |
| Regulation Numbers: | 888.3080 - Intervertebral Body Fusion Device<br>888.3060 - Spinal Intervertebral Body Fixation Orthosis | |
#### Substantially Equivalent Devices:
- · Blackstone Medical, Inc. Construx PL/TL Partial VBR Spacers (K060350 SE 2-24-06)
- · Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05)
- · Blackstone Medical, Inc. PILLAR Spacer System (K081177 SE 7-23-08)
- · Surgicraft, Ltd. STALIF TT (K041617 SE 9-8-04 and K051027 SE 6-29-05)
- · Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109 SE 6-4-08)
- · Medtronic Sofamor Danek, Intrepid Spinal System (K080083 SE 4-10-08)
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2081849
Premarket Notification Special 510(k) Blackstone Medical, Inc. PILLAR SA PEEK Spacer System System Modification
#### Device Description:
The Blackstone Medical, Inc. PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from Polyetheretherketone (PEEK-OPTIMA® LT1), as described by ASTM F-2026, with tantalum markers as described by ASTM F-560. The implants are available in multiple footprint sizes, and a variety of heights and angles of lordosis. The implants incorporate integrated anterior screw holes to allow for medial placement of titanium screws that anchor to the vertebrae, as well as a titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent movement of the device.
#### Intended Use / Indications for Use:
## When used as an Intervertebral Body Fusion System:
The PILLAR™ SA PEEK Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft.
The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System.
#### When used as a Partial Vertebral Body Replacement (VBR) System:
The PILLAR™ SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR™ SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of
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Image /page/2/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "Kb81849i". The characters are written in a dark ink on a white background. The handwriting is somewhat messy and difficult to read.
fusion for a prolonged period of time. The PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft.
The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).
#### Basis of Substantial Equivalence:
Based on mechanical performance data and equivalence in configuration and indications for use, the Blackstone PILLAR SA PEEK Spacer System is substantially equivalent to the following devices, which have been cleared by FDA for the purpose of building a spinal implant construct in the non-cervical spine:
- · Blackstone Medical, Inc. Construx PL/TL Partial VBR Spacers (K060350 SE 2-24-06)
- · Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05)
- · Blackstone Medical, Inc. PILLAR Spacer System (K081177 SE 7-23-08)
- · Surgicraft, Ltd., STALIF TT (K051027 SE 6-29-05 and K041617 SE 9-8-04)
- · Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109 SE 6-4-08)
- · Medtronic Sofamor Danek, Intrepid Spinal System (K080083 SE 4-10-08)
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 12 2011
Blackstone Medical, Inc. % Ms. Whitney G. Törning Senior Director of Regulatory Affairs and Quality Assurance 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470
Re: K081849
> Trade/Device Name: Blackstone PILLAR™ SA PEEK Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MQP Dated: July 30, 2008 Received: July 31, 2008
Dear Ms. Törning:
This letter corrects our substantially equivalent letter of August 28, 2008.
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 (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.
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
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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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark M. Wilkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Blackstone PILLAR™ SA PEEK Spacer System
Indications for Use:
## When used as an Intervertebral Body Fusion System:
The PILLAR™ SA PEEK Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft.
The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System.
When used as a Partial Vertebral Body Replacement (VBR) System:
The PILLAR™ SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.
The PILLAR™ SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft.
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# 1081849
The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).
Prescription Use _ X AND/OR Over-The-Counter Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2
Soubare buellin
Division of General, Restorative, and Neurological Devices
**510(k) Number** K081846
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.
