K051195 · Osteotech, Inc. · MBP · Dec 16, 2005 · Orthopedic
Device Facts
Record ID
K051195
Device Name
GRAFTON DBM
Applicant
Osteotech, Inc.
Product Code
MBP · Orthopedic
Decision Date
Dec 16, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3045
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
GRAFTON® DBM is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities); created defects or defects created by trauma to the bone. In and is resorbed/remodeled and is replaced by host bone during the healing process.
Device Story
GRAFTON® DBM is a human bone allograft product consisting of demineralized bone matrix (DBM) and an inert carrier; used as a bone void filler, graft extender, or substitute. Provided ready-to-use in various physical forms (gel, flex, putty, matrix, crunch, orthoblend) to allow for molding, cutting, or manipulation by surgeons during orthopedic or spinal procedures. The device is osteoconductive and osteoinductive; it fills bony voids or gaps, providing stability to the skeletal structure while being resorbed and remodeled into host bone during the healing process. The product undergoes a proprietary viral inactivation process to reduce disease transmission risk. It is intended for prescription use by clinicians to treat skeletal defects.
Clinical Evidence
Performance supported by animal and human studies. Osteoinductivity is confirmed via a validated athymic rat assay, scoring bone formation at 28 days. Viral inactivation efficacy validated against HIV-1, hepatitis B, hepatitis C, and polio viruses. Clinical performance is supported by existing data demonstrating successful outcomes comparable to predicate devices.
Technological Characteristics
Human demineralized bone matrix (DBM) allograft with inert carrier. Physical forms include gel, flex, putty, matrix, crunch, and orthoblend. Osteoconductive and osteoinductive properties. Proprietary viral inactivation process for DBM component. Resorbable bone void filler. Class II device.
Indications for Use
Indicated for use as a bone graft extender, bone graft substitute, and bone void filler in surgically created or trauma-induced bony voids or gaps of the skeletal system, including the spine, pelvis, and extremities, to provide stability to the bony structure.
Regulatory Classification
Identification
A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
Submission Summary (Full Text)
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K051195
## DEC 1 6 2005
## XII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
December 15, 2005
- 1. Submission Applicant & Correspondent:
| Name: | Osteotech, Inc. |
|-----------------|-------------------------------------|
| Address: | 51 James Way<br>Eatontown, NJ 07724 |
| Phone No.: | (732) 542-2800 |
| Contact Person: | Chris Talbot |
- 2. Name of Product:
| Trade/Proprietary/Model Name: | GRAFTON® DBM (Gel, Flex, Putty, Matrix<br>Crunch, Orthoblend) |
|-------------------------------|---------------------------------------------------------------|
| Common or Usual Name: | Demineralized Bone Matrix Allograft |
| Classification Name: | Resorbable Bone Void Filler |
- 3. Devices to Which New Product is Substantially Equivalent:
GRAFTON® DBM is substantially equivalent, for the purpose of this 510(k), to other devices that have received 510(k) clearance for similar indications for use.
- 4. Device Description:
GRAFTON®DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative deminerallizon bone matinr use in filling bony voids or gaps of the skeletal system nanding. It is internativility of the bony structure. GRAFTON® DBM is provided ready-to-use in various physical forms and in various package sizes by volume or dimension.
GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary woll as betterfuler of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON® DBM product for osteoinductivity in this validated athymic rat assay utilizing a missica product for occomise , a to score bone formation at 28 days*. This bone five point linear boals (0) 7/2/07/27TON® DBM in this athymic rat surrogate assay should not be interpreted as a predictor of clinical performance.
*Edwards, J.T., PhD, Diegmann, M.H., MS, Scarborough, N.L., PhD.: Osteoinduction of Human Edwards, a. F., F.B., Diogramm, Rating in a Rat Model. Clinical Orthopaedics, December, 1998, Volume 357.
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- 5. Intended Use/Indications
GRAFTON® DBM is intended for use as a bone graft extender, bone graft GRAFTON - DDM is interiaculation as a sor gaps of the skeletal system (i.e., substitute, and bone vold micr in bony volto the stability of the bony structure. spine, peris and Oxtromitios); created defects or defects or defects created by The volus of gaps may be bargiously on the bone. In and is resorbed/remodeled and is treplaced by host bone during the healing process
- 6. Technical Comparison
GRAFTON® DBM is substantially equivalent to one or more of the predicate devices with respect to materials in that it contains human demineralized bone devices with respect to matemals in the enditive or carrier. It is provided readymatin (DDM) in a roonbable non of that can be molded, manipulated or cut to-use in various malicablomoxible room or sizes. It is implanted in this malleable/flexible state.
- 7. Performance Data
The results of studies in animals and humans showed that GRAFTON® DBM THE TESGIRS of Station ell as, if not better than, predicate devices and/or performs at load. as not animal and clinical data exist that support the successful performance of GRAFTON® DBM.
- 8. Viral Inactivation
The DBM in GRAFTON® DBM is produced by a proprietary production process that has been validated to inactivate viruses including: HIV-1; hepatitis B virus (duck hepatitis virus as model); hepatitis C virus (bovine diarrhea virus as (adok hopatitio virus as mous , This process is used to further reduce the risk of model), OMY, and Pollo the use of this product beyond the protection provided by donor testing and screening procedures.
The process used to produce the non-demineralized cancellous bone chips in Grafton® DBM Orthoblend does not afford the same degree of viral inactivation as the process used to produce the DBM. However, the risk of disease as the prooooo used to proac component remains low due to multiple safeguards that are rigorously employed, including donor screening, laboratory testing and material processing.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2005
Mr. Christopher Talbot Director, Regulatory Affairs Osteotech, Inc. 51 James Way Eatontown, NJ 07724
Re: K051195
GRAFTON ® DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MQV Dated: September 16, 2005 Received: September 19, 2005
Dear Mr. Talbot:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater on edited is substantially equivalent (for the itelered above and have acteriminoure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to dovroes that in i e Act (Act) that do not require approval of a premarket the rederal I ood, Drag, and Commonsy, therefore, market the device, subject to the general approvin uppheation (The Act. The general controls provisions of the Act include controls provideons of the sixtration, 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 17 your device to such additional controls. Existing major regulations affecting (1 Nr.), it may of subject to tack adde of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Cours nouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advised that 1 DT of issualise on that your device complies with other requirements mean that I Dr I has made statutes and regulations administered by other Federal agencies.
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Page 2 – Mr. Christopher Talbot
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Act s requirements int 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Par and listing (21 CFR Part 807), labeling (21 CFR Part 807), Books (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Parts A requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section This letter will anow you to ocgin marketing your es substantial equivalence of your device and thus ว I 0(K) premarket notification: The 1 DA minute of our 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 Patt 801), If you desire specific advice for your device on our labor, also, please note the regulation please contact the Office of Comphance at (210) = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sman Manaka (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Melkerson. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use – Statement 111.
510(k) Number (if known): K051195
Device Name: GRAFTON ®DBM
Indications for Use:
GRAFTON® DBM is intended for use as a bone graft extender, bone graft GRAFTON "DDM is intended for acc access of the skeletal system.
substitute, and bone void filler in bony voids or gaps of the first hany Substitute, and bone vold mior in bony volume to the stability of the bony (I.E., Spine, perios and Oxtronikas) he surgically created defects or defects Structure. The volue of gapo the bone. GRAFTON® DBM is created by tradmationing to the bel by host bone during the healing process.
Prescription Use__X (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
bare Bonem for mxm
Title: Sign Off
ral. Restorative, Division of Get and Neurological Devices
**510(k) Number** K051195
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.
