STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
Applicant
Stryker Instruments
Product Code
HBE · Neurology
Decision Date
Jan 16, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 882.4310
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and bone cement in a variety of surgical procedures, including but not limited to Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The endoscopic applications with CORE include use with the SE5 Small Joint Shaver in the wrist for any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.
Device Story
Stryker CORE System is a powered surgical console for driving various surgical instruments; includes drills, shavers, saws, and wire drivers. System components include console, irrigation pump, footswitch, handswitch, and handpieces. Used in operating rooms by surgeons for bone/tissue manipulation and fixation hardware placement. Console provides power and control to attachments; surgeon operates via footswitch or handswitch. Output is mechanical rotation or oscillation of surgical bits/blades. Benefits include precise bone/tissue resection and efficient hardware installation during orthopedic, neuro, and endoscopic procedures.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Powered surgical console system. Includes motors, attachments, irrigation pump, and control interfaces (footswitch/handswitch). Connectivity via cords/cables. System is designed for integration with various surgical handpieces (drills, shavers, saws).
Indications for Use
Indicated for patients requiring bone/bone cement cutting, drilling, reaming, decorticating, or smoothing during surgical procedures (e.g., Neuro, Endoscopic). Includes endoscopic tissue morselization, debridement of synovitis/cartilage/ligaments, and management of osseous lesions (osteophytes/eburnated surfaces). Also indicated for placement/cutting of fixation hardware (screws, wires, pins).
Regulatory Classification
Identification
Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.
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## 510(k) Summary
. -
大032303
| Trade Name: | Stryker Consolidated Operating Room Equipment (CORE) System |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Console |
| Classification Names: | Bone Cutting Instruments and Accessories. (per 21 CFR section<br>872.4120)<br>Ear, Nose and Throat Electric or Pneumatic Surgical Drill. (per 21<br>CFR section 874.4250)<br>Powered Simple Cranial Drill, Burrs, Trephines and their Accessories<br>(per 21 CFR section 882.4310) |
| Equivalent to: | Stryker TPS (Dental-K943540, ENT-K943569, Neuro- 943541), TPS<br>Hermes (991696), Stryker Navigation System (K012380) and Dyonics<br>(K771218). |
| Device Description: | The device description of the Stryker System includes drills, shavers,<br>shields, guards, motors, attachments, saws, wire drivers, collets,<br>console, irrigation pump, cords, footswitch, handswitch, clips, tubing,<br>cutting accessories, and sterilization cases.<br>The scope of this modification is limited to the console of the system. |
| Intended Use: | The Stryker Consolidated Operating Room Equipment (CORE) System<br>is intended for use in the cutting, drilling, reaming, decorticating, and<br>smoothing of bone and bone cement in a variety of surgical<br>procedures, including but not limited to Neuro and Endoscopic. It is<br>also usable in the placement or cutting of screws, metal, wires, pins,<br>and other fixation devices. |
| | The endoscopic applications with CORE include use with the SE5<br>Small Joint Shaver in the wrist for any need for morselization of tissue<br>within the joint. Cutters will be used to debride synovitis, articular<br>cartilage flaps, or torn ligaments when surgeons deem resection<br>appropriate. Burs are indicated for management of osseous lesions<br>such as eburnated articular surfaces or osteophytes. |
| Technological<br>Comparison: | Technological characteristics are the same as previously cleared<br>for the Stryker TPS System (K943540, K943569, K943541, and<br>K991696), Stryker Navigation System (K012380) and Dyonics<br>(K771218). |
| Submitted by: | Jean W. Sheppard<br>Sr. Regulatory Affairs Representative<br>Stryker Instruments<br>July 24, 2003 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white and has a simple, clean design.
JAN 1 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jean W. Sheppard Sr. Regulatory Affairs Representative Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K032303
Trade/Device Name: Stryker Consolidated Operating Room Equipment (CORE) Console Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and their accessories Regulatory Class: II Product Codc: HBE Dated: October 20, 2003 Received: October 21, 2003
Dear Ms. Sheppard:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been worked 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 encreative to the enactment date of the Medical Device Amendments, or to conniner of the rial) 2011-11-3) in accordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alle Costiette Act (71ct) that to hot requestly of the general controls provisions of the Act. The r ou may, merelere, mainer of the Act include requirements for annual registration, listing of general controls provisions of are tice, 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 If your device is classified (500 abor of the existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Court of Counts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuated of a basenia.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regulations and annualing, but not limited to: registration and listing (21 comply with an the Act s requirements, me; good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the clectronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Jean W. Sheppard
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your antial equivalence of your deversity your develop premarket nothcation. THE PDA Intellig of babbankal via revice 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 If you desire specific atvice for your do rice of the same of the regulation entitled, and comact the Office of Compliance an (21CFR Part 807.97). You may obtain "Whisoranding by relevelee to premail.org.ibilities under the Act from the Division of Small other general informational 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Colia 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 Statement
510(k) Number (if known): K032303
The Stryker Consolidated Operating Room Equipment (CORE) Device Name System
- The Stryker Consolidated Operating Room Equipment (CORE)System is Indications intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and bone cement in a variety of surgical procedures, including but not limited to Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The endoscopic applications with CORE include use with the SE5 Small Joint Shaver in the wrist for any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.
Prescription Use _ X (Per 21 CFR 801 Subpart D) Over-The-Counter Use _ (21 CFR 807 Subpart C)
## (IPLEASE DO NOT WRITE BELOW THISS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Sivision Sign-Off) Division of General, Restorative and Neurological Devices
K632303 (1) Number ...
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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.
