Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Stryker® Injectable Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process.
Device Story
Stryker® Injectable Cement is a self-setting calcium phosphate bone void filler. It is prepared and injected by a surgeon into bony voids or gaps in the extremities, craniofacial region, spine, or pelvis. The cement cures in situ to act as a temporary filler and to augment provisional hardware (e.g., K-wires, plates, screws) for supporting bone fragments during surgical procedures. It is not intended to provide structural support during the healing process. The device is used in an operating room setting.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Self-setting calcium phosphate cement. Formulated as a bone void filler. Material properties and curing characteristics are consistent with previously cleared calcium phosphate cements. No electronic components, software, or connectivity.
Indications for Use
Indicated for filling bony voids or gaps in the skeletal system (extremities, craniofacial, spine, pelvis) resulting from surgery or traumatic injury. Not for use in defects intrinsic to the stability of the bony structure. Used to augment provisional hardware (K-wires, plates, screws) for temporary support of bone fragments during surgery.
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.
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Koloobl
#### 2006 MAR I
# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Stryker® Injectable Cement
#### General Information
| Proprietary Name: | Stryker® Injectable Cement |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Hydroxyapatite Cement |
| Proposed Regulatory Class: | Class II |
| Device Classification: | MQV (21 CFR 888.3045) Filler, bone void, calcium compound<br>FMF (21 CFR 880.5860) Syringe, Piston |
| Submitter: | Stryker®<br>750 Trade Centre Way<br>Suite 200<br>Kalamazoo, MI 49002<br>877-534-2464 x 4226 |
| Submitter's Registration #: | 8010177 |
| Manufacturer's Registration #: | 9610726 |
| Contact Person: | Wade T. Rutkoskie<br>Manager, Regulatory Affairs and Quality Assurance<br>Phone: 877-534-2464 x 4226<br>Fax: 269-323-4215 |
| Summary Preparation Date: | January 4, 2006 |
#### Intended Use
Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Stryker® Injectable Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process.
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Substantial Equivalency Information
Stryker@ Injectable Cement is substantially equivalent to legally marketed K051603 Stryker@ Stryker@ Injectable Cement Is Substantany oqurralent to regally with Medical MIIG II and K042516 Walter Lorenz Otomimix.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized caduceus, a symbol often associated with healthcare, alongside the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion. The caduceus is depicted with a series of curved lines, representing a staff with intertwined snakes, and the text is in a simple, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR I 2006
Mr. Wade T. Rutkoskie Manager, Regulatory and Quality Affairs Stryker® CMF 750 Trade Centre Way Kalamazoo, Michigan 49001
Re: K060061
Trade/Device Name: Stryker® Injectable Cement Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, FMF Dated: January 4, 2006 Received: January 9, 2006
Dear Mr. Rutkoskie:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected. Decembed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal the encreases of 776, the enactment date of the Medical Device Amendments, or to conninered pror to May 2011/09/2017 11:12 provisions of the Federal Food. Drug. de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains 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 such additional controls. Existing major regulations affecting your device can may or babyer it 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); good manufacturing practice requirements as set
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Page 2 - Mr. Wade T. Rutkoskie
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. product railation of the only in begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Heekul Leuer 10
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Page 1 of 1
## 510(K) Number (if known): K O60066
## Device Name: Stryker® Injectable Cement
### Indications for Use:
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Stryker® Injectable Cement cured in situ provides an open void/gap filler that can Sugment provisional hardware (e.g., K-Wires, plates, screws) to help support bone aughtent provisional narawal (05) .
fragments during the surgical procedure. The cured cement acts only as a temporary fragments during the surgled provide structural support during the healing process.
AND/OR X Prescription Use (21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Page
Herbert Lewis
of
Division of General, Restorative, and Neurological Devices
*10(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.
