K000666 · Plus Orthopedics · JWH · Oct 13, 2000 · Orthopedic
Device Facts
Record ID
K000666
Device Name
TC-PLUS SOLUTION KNEE
Applicant
Plus Orthopedics
Product Code
JWH · Orthopedic
Decision Date
Oct 13, 2000
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3560
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The TC-PLUS™ Solution Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, post-traumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.
Device Story
TC-PLUS™ Solution Knee is a tri-compartmental total knee prosthesis; includes femoral, patellar, and tibial components. Available in Standard, Posterior Stabilized (PS), and Ultracongruent options to address stability requirements. Designed for cemented surface replacement in primary or revision arthroplasty. Used by orthopedic surgeons in clinical/OR settings. Device restores joint function and stability in patients with degenerative or post-traumatic knee conditions. Biomechanical testing confirms suitability for in vivo loading.
Clinical Evidence
Bench testing only. Biomechanical testing provided to support safety and effectiveness for in vivo loading.
Technological Characteristics
Tri-compartmental total knee prosthesis; components: femoral, patellar, tibial. Materials: Polymer/Metal/Polymer. Configuration: Standard, Posterior Stabilized (PS), and Ultracongruent options. Fixation: Cemented. Energy source: None (mechanical).
Indications for Use
Indicated for patients requiring primary or revision total knee arthroplasty due to degenerative, post-traumatic, or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic joint configuration loss, patello-femoral erosion, functional disability, prior patellectomy, or moderate varus/valgus/flexure deformity. Contraindications: acute/chronic infection, severe muscular/neurological/vascular deficiency, insufficient bone quality, severe obesity, material allergy, femoral subluxation, ligament instability, severe misalignment, retropatellar degenerative arthritis, or extension contractures >10°.
Regulatory Classification
Identification
A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
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## 510(k) Summary of Safety and Effectiveness
August 24, 2000
- Contact: Hartmut Loch, C.E.O. PLUS ORTHOPEDICS 3550 General Atomics Court, Bldg. 15-100 San Diego, CA 92121
- TC-PLUS™ Solution Knee Trade name:
- Knee Joint Prosthesis Common name:
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Classification name: Polymer/Metal/Polymer
- Encore Foundation Knee System (K923277, SE date 02/09/93) Equivalence:
- The TC-PLUS™ Solution is a tri-compartmental total knee prosthesis Characteristics: comprised of femoral, patellar and tibial components with an intrinsic Standard, Posterior Stabilized (PS) and Ultratibial PE-insert. Congruent components are available. The PS is available for indications requiring greater stability and the Ultracongruent option may be used as an alternative for increasing A/P stability.
- The TC-PLUS™ Solution Knee is intended as a cemented surface Indications: replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for post-traumatic or rheumatoid arthritis, avascular degenerative, necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.
- Contraindications include acute or chronic infections (local or Contraindications: systemic) or a history of infection; severe muscular, neurological, or vascular deficiencies which compromise the affected extremity; bone defects or insufficient bone quality which may affect the stability of the implant; any concomitant illness which may compromise the function of the implant; severe obesity; allergy to the implant materials; subluxation of the femur against the eminentia; ligament instability; severe varus or valgus misalignment; retropatellar degenerative arthritis; extension contractures over 10°.
- Biomechanical Testing has been provided. Performance data: All test results are sufficient for in vivo loading.
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## OCT 1 3 2000
Mr. Hartmut Loch Chief Executive Officer PLUS Orthopedics 3550 General Atomics Court Building 15-100 San Diego, California 92121-1122
Re: K000666
Trade Name: TC-PLUS Solution Knee Regulatory Class: II Product Code: JWH Dated: August 24, 2000 Received: August 25, 2000
Dear Mr. Loch:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 910(x) notification of the indications for use indications for use above and we nave determined the devices marketed in interstate commerce prior to May 28, 1976, the stated in the enclosure) to device Amendments, or to devices that have been reclassified in enactment date of the Medical Device Frinencine, or we and Cosmetic Act.(Act). You may, a therefore, market the device, subject to the general control provisions of the Act. The general therefore, market the device, subject to the generatis for annual registration, listing of devices to control provisions of the Ace merade requirements instranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (see above) anto such additional controls. Existing major.regulations (Premarket Approval), it may of subject to ace of Federal Regulations, Title 21, Parts 800 to 895. arrecting your de rive eant determination assumes compliance with the current Good A substantiany equirement, 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 mspections, the rood and Drug Nammedia in to allatory action. In addition, FDA may publish Continy with the GMI Togatazen in the Federal Register. Please note: this response to your premarks contring your submission does not affect any obligation you might Its pour premainter as and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouticate device results in a classification for your device and thus, permits your device to proceed to the market.
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## Page 2 - Mr. Hartmut Loch
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and IT you desire specific davice for your actic devices), please contact the Office of Compliance at additionally 807.10 for in Vitto diagnostions on the promotion and advertising of your device, (2017) 594-4037. Additionally, for quose at (301) 594-4639. Also, please note the regulation prease connect the Orneo or Somphares et premarket notification" (21 CFR 807.97). Other general entitled, "Misoranding by relection to premation to may be obtained from the Division of Small information on your responsionneer and its tollows 38-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark n Mellausen
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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Premarket Notification 510(k) TC-PLUS™ Solution Knee August 24, 2000
Page 1 of 1
510(k) Number (if known): _KOOO 666
Device Name: TC-PLUS™ Solution Knee
Indications for Use:
The TC-PLUS™M Solution Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasty. It is indicated for degenerative, post-traumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milliman
Division Sign-C (Division of General Restorative 510(k) Number
Prescription Use X (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.
