PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE
Applicant
Interpore Cross Intl.
Product Code
MQV · Orthopedic
Decision Date
Mar 2, 1999
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3045
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Pro Osteon 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremeities, 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 resorbs and is replaced with bone during the healing process.
Device Story
Pro Osteon 500R is an osteoconductive, porous bone graft substitute; structure mimics human cancellous bone. Implant consists of trabecular calcium carbonate core with thin (2-10 micron) calcium phosphate outer layer. Supplied sterile in various shapes/sizes. Used by surgeons in clinical settings to fill non-structural osseous defects. Surgeon packs material into void; material acts as scaffold for tissue infiltration and bone apposition. Calcium phosphate layer resorbs slowly, followed by faster resorption of calcium carbonate core (within 6 months). Replaced by host bone/soft tissue during healing. Requires rigid fixation; does not provide mechanical support. Radiopaque until resorbed.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Porous trabecular calcium carbonate core; calcium phosphate outer coating (approx. 13% of structure, 2-10 microns thick). Median pore diameter 435 microns. Radiopaque. Sterile, non-resorbable mechanical support not provided. No software or electronic components.
Indications for Use
Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability. Defects may be surgically created or traumatic. Contraindicated for growth plate fractures, segmental defects, sites subject to excessive stress, significant vascular impairment, metabolic/systemic bone healing disorders, unstable fractures, or infected sites.
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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## 510(k) SUMMARY
**SUBMITTED BY**
K 990/31
Lynn Rodarti Manager, Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618
(949) 453-3200
January 13, 1999
# CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Filler, Bone Void, Non-Osteoinductive Common/Usual Name: Bone Graft Substitute, Bone Void Filler Product Classification: Unclassified Proprietary Name: Pro Osteon® 500R Resorbable Bone Graft Substitute
### INDICATIONS-FOR-USE
Pro Osteon 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon® 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., 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 resorbs and is replaced with bone during the healing process.
# DEVICE DESCRIPTION
Pro Osteon® 500R Resorbable Bone Graft Substitute is an osteoconductive porous implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes.
Pro Osteon® 500R has a trabecular structure that resembles the multidirectional interconnected porosity of cancellous bone. It has a median pore diameter of 435 microns. The implant is trabecular calcium carbonate covered by a very thin outer layer of calcium phosphate representing approximately 13% of the total implant structure. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. It is approximately 2 to 10 microns in thickness and overlays the calcium carbonate substructure. Once implanted, the calcium phosphate outer layer will slowly
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resorb, delaying exposure of the underlying and faster resorbing calcium carbonate, Calcium carbonate resorption will normally occur within six months or less.
When Pro Osteon® 500R is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the Pro Osteon® 500R surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the implant.
# CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND COMPLICATIONS
#### 1. Contraindications
Pro Osteon® 500R is contraindicated for fractures of the growth plate; for segmental defects; for indications which may be subjected to excessive impact or stresses; when there is significant vascular impairment proximal to the graft site; when there are metabolic or systemic disorders that affect bone or wound healing: when stabilization of the fracture is not possible; in cases where intraoperative soft tissue coverage is not planned or possible, and in infected sites.
- 2. Warning and Precautions
Pro Osteon® 500R does not possess sufficient mechanical strength to support reduction of a defect site prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure rigid stabilization of the defect in all planes. Pro Osteon® 500R Resorbable Bone Graft Substitute is intended for use by surgeons familiar with bone grafting and rigid fixation techniques. Complete postoperative wound closure is essential.
Pro Osteon® 500R is radiopaque until resorbed. Radiopacity may mask underlying pathological conditions. Radiopacity may also make it difficult to radiographically assess the ingrowth of new bone.
- 3. Potential complications using this device are the same as those encountered in autogenous bone grafting procedures and include the following: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, nonunion, wound dehiscence, delayed union, malunion, loss of reduction, refracture, cyst recurrence, hematoma, and cellulitis.
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Image /page/2/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 or bird in flight, composed of three curved lines. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 1999
Ms. Lynn M. Rodarti Manager, Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618-2402
Re: K990131 Pro Osteon® 500R Resorbable Bone Graft Substitute Regulatory Class: Unclassified Product Code: MQV Dated: January 13, 1999 January 14, 1999 Received:
Dear Ms. Rodarti:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Lynn M. Rodarti
This letter will allow you to beqin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K990131/
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Page 1 of 1
# 510(k) Number (if known):
Pro Osteon® Bone Graft Substitute Device Name:
# Indications-For-Use:
Pro Osteon 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremeities, 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 resorbs and is replaced with bone during the healing process.
# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Acostafo
(Division Division of General Rest 510(k) Numbe
Prescription Use (PER 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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.
