K043420 · Regeneration Technologies, Inc. · MQV · Feb 10, 2005 · Orthopedic
Device Facts
Record ID
K043420
Device Name
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
Applicant
Regeneration Technologies, Inc.
Product Code
MQV · Orthopedic
Decision Date
Feb 10, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3045
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
REGENAFIL® Allograft Paste; REGENAFIL® RT Allograft Paste; OPTEFIL™ Allograft Paste, Syringe; OPTEFIL™ RT Allograft Paste, Syringe; OSTEOFIL® DBM Paste; OSTEOFIL® RT DBM Paste; and RTI Allograft Paste are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Device Story
Bone graft substitute paste composed of demineralized bone matrix (DBM) and gelatin carrier; functions as scaffold for osteoconduction; provides osteoinductive properties. Intended for surgical placement into non-structural bony voids or gaps in extremities, spine, or pelvis. Remodels into recipient's skeletal system over time. Used by surgeons in clinical settings to fill osseous defects resulting from surgery or trauma.
Clinical Evidence
No human clinical data provided. Evidence based on non-clinical animal model studies evaluating healing radiographically, histologically, and mechanically. DBM and finished product screened for osteoinductivity via rat assay.
Technological Characteristics
Composition: Allograft demineralized bone matrix (DBM) in a gelatin carrier. Function: Osteoconductive scaffold and osteoinductive agent. Form factor: Paste (some provided in syringes). Sterilization: Not specified.
Indications for Use
Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to bony stability. Defects may be surgically created or result from traumatic injury. Contraindications not specified.
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.
Predicate Devices
Pro Osteon™ Implant 500R Resorbable Bone Graft Substitute
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for Regeneration Technologies, Inc. The word "Regeneration" is in large, bold, black letters. Below it, in smaller letters, is the phrase "TECHNOLOGIES, INC."
11621 Research Circle Post Office Box 2650 Alachua. FL 32616-2650 USA
Tel 386.418.8888 Toll Free 877 343.6832 Fax 386.413.0542 www.rtix.com
## 510(K) Summary
February 2, 2005 Date:
Submitted by: Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle P.O. Box 2650 Alachua, FL 32616-2650 386-418-8888 Telephone: 386-462-3821 Facsimile:
Proprietary Name: REGENAFIL® Allograft Paste REGENAFIL® RT Allograft Paste OPTEFILTM Allograft Paste, Syringe OPTEFIL™ RT Allograft Paste, Syringe OSTEOFIL® DBM Paste OSTEOFIL® RT DBM Paste RTI Allograft Paste
Common Name: Bone Void Filler, Bone Graft Substitute
Classification Name: Filler, Calcium Sulfate Preformed Pellets (per 21CFR section 888.3045)
Predicate Devices:
The current devices have the same indications as and are substantially equivalent to the Pro Osteon™ Implant 500R Resorbable Bone Graft Substitute.
Description:
These devices are bone paste products made by combining gelatin and demineralized bone matrix.
Indications for Use:
REGENAFIL® Allograft Paste; REGENAFIL® RT Allograft Paste; OPTEFIL™ Allograft Paste, Syringe; OPTEFIL™ RT Allograft Paste, Syringe; OSTEOFIL® DBM Paste; OSTEOFIL® RT DBM Paste; and RTI Allograft Paste are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are
K Ö43420
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indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremittes, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
## Summary of Technological Characteristics:
These devices are composed of allograft demineralized bone in a gelatin carrier matrix. These devices have been screened for osteoinductivity in an in vivo assay and also provide a scaffold for osteoconduction. The processed coral in the Pro Osteon® Implant 500R Resorbable Bone Graft Substitute provides a scaffold for osteoconduction.
Non-Clinical Performance Data Supporting Substantial Equivalence Determination: Results from studies in animal models indicate that these products can be used as a bone graft substitute with equivalent or better healing results when compared to the predicate device. Healing was evaluated radiographically, histologically, and mechanically.
<sup>1</sup> DBM and finished product were screened for osteoinductivity in a rat assay. Findings from an animal model are not necessarily predictive of human clinical results.
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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 & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the eagle.
FEB 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Regeneration Technologies, Inc C/o Ms. Carrie Hartill 11621 Research Circle P.O. Box 2650 Alachua, Florida 32616-2650
Re: K043420
Ro43420
Trade Name: REGENAFIL® Allograft Paste, REGENAFIL® RT Allograft Paste, OPTEFILTM Allograft Paste, Syringe, OPTEFIL™ RT Allograft Paste, OP TEFIL™ Anografi Paste, Syrings, OF FEFIL® - TEFFE - Tell Frances
Syringe, OSTEOFIL® DBM Paste, OSTEOFIL® RT DBM Paste and RTI Allograft Paste Regulation Number: 21 CFR 888.3045 Regulation Name: Reabsorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: December 9, 2004 Received: December 13, 2004
Dear Ms. Hartill:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becareer and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatives to the enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic rear (110.) that the device, subject to the general controls provisions of the Act. The I ou may, merelore, mannet 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 your device is etablifical controls. Existing major regulations affecting your device it may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA oun of the firther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be deviloed that I 19 mination that your device complies with other requirements of the Act that I DI has intass and regulations administered by other Federal agencies. You must or any I catal statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quand provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Carrie Hartill
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse organ finding of substantial equivalence of your device to a legally premarce issues in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific at (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general michinal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Sincerely yours,
Mark A. Millam
Celia M. Witten, Ph. D. M.D. 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
510(k) Number (if known): K043420
Device Name:
REGENAFIL® Allograft Paste REGENAFIL® RT Allograft Paste OPTEFIL™ Allograft Paste, Syringe OPTEFILTM RT Allograft Paste, Syringe OSTEOFIL® DBM Paste OSTEOFIL® RT DBM Paste RTI Allograft Paste
Indications for Use:
These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
*Minh M*
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
K043420
510(k) Number
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.
