K180159 · Total Joint Orthopedics, Inc. · JWH · Mar 9, 2018 · Orthopedic
Device Facts
Record ID
K180159
Device Name
Klassic® Knee System
Applicant
Total Joint Orthopedics, Inc.
Product Code
JWH · Orthopedic
Decision Date
Mar 9, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3560
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Klassic® Knee System is intended for prosthetic replacement of the following: · Patient conditions of non-inflammatory degenerative joint disease (NID): avascular necrosis and osteoarthritis · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis · Patients with failed previous surgery where pain, deformity, or dysfunction persists · Correctable varus-valgus deformity and moderate flexion contracture · Revision of a previously failed knee arthroplasty · Patients who require a total knee replacement The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
Device Story
Klassic® Knee System components (tibial inserts and patellae) provide prosthetic knee replacement; intended for patients with degenerative or inflammatory joint disease, or failed prior surgery. Components manufactured from E-Link® (Vitamin E blended, gamma-irradiated UHMWPE). System includes CR/Congruent Tibial Inserts, Ultra-PS® Tibial Inserts, Sombrero Patellae, and Domed Patellae. Used by orthopedic surgeons in clinical/surgical settings. Device replaces damaged joint surfaces to restore function and reduce pain. Substantial equivalence established via engineering analysis and bench testing comparing wear, stability, range of motion, and modular disassembly against predicate components.
Clinical Evidence
Bench testing only. No clinical data presented. Testing included wear evaluation of worst-case constructs, tibial-femoral stability, stress distribution, range of motion, tibial modular disassembly, and patella-femoral resistance to lateral subluxation. LAL testing for orthopedic implants performed.
Technological Characteristics
Components manufactured from E-Link® (Vitamin E blended, gamma-irradiated UHMWPE). Semi-constrained design for patellofemorotibial replacement. Available in various sizes/thicknesses. Cemented or cementless fixation depending on component type. Compliant with LAL testing requirements.
Indications for Use
Indicated for patients requiring total knee replacement due to non-inflammatory degenerative joint disease (avascular necrosis, osteoarthritis), inflammatory joint disease (rheumatoid arthritis), failed previous surgery, or revision of failed knee arthroplasty. Suitable for patients with correctable varus-valgus deformity and moderate flexion contracture.
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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March 9, 2018
Total Joint Orthopedics, Inc. Chris Weaber Product Development, Regulatory Manager 1567 E. Stratford Avenue Salt Lake City, Utah 84106
### Re: K180159
Trade/Device Name: Klassic® Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: January 19, 2018 Received: January 19, 2018
Dear Chris Weaber:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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K180159
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K180159
Device Name Klassic® Knee System
### Indications for Use (Describe)
- The Klassic® Knee System is intended for prosthetic replacement of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NID): avascular necrosis and osteoarthritis
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- · Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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## 5. 510(k) Summary
| Manufacturer: | Total Joint Orthopedics, Inc.<br>1567 E. Stratford Avenue<br>Salt Lake City, UT 84106<br>Phone: 801.486.6070<br>Fax: 801.486.6117 | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Contact: | Mr. Chris Weaber<br>Product Development, Regulatory Manager | |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC<br>1050 K Street, NW, Suite 1000<br>Washington, DC 20001<br>Phone: 202.552.5800 | |
| Date Prepared: | January 19, 2018 | |
| Device Trade Name: | Klassic® Knee System | |
| Device Common Name: | Tibial Inserts and Patellae | |
| Classification: | 21 CFR 888.3560 – Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented<br>21 CFR 888.3565 Knee joint patellofemorotibial<br>metal/polymer porous-coated uncemented prosthesis<br>Class II | |
| | Product Codes: | JWH, MBH |
### Indications for Use:
The Klassic® Knee System is intended for prosthetic replacement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJ): . avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis ●
- Patients with failed previous surgery where pain, deformity, or dysfunction . persists
- . Correctable varus-valgus deformity and moderate flexion contracture
- Revision of a previously failed knee arthroplasty .
- . Patients who require a total knee replacement
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The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.
## Device Description:
The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts with E-Link®, Ultra-PS® Tibial Inserts with E-Link®, Sombrero Patellae with E-Link® and Domed Patellae with E-Link® ("E-Link® Knee Components") to the Klassic® Knee System. These components are manufactured from E-link®, a Vitamin E blended UHMWPE crosslinked by gamma irradiation. The E-Link® Knee Components are available in various sizes and thicknesses to match patient anatomy.
## Predicate Devices:
The E-Link® Knee Components are substantially equivalent to the predicate Klassic® Knee System Components (K112906, K140942, K150105, K153075, K153310, and K162422) with respect to indications, design, and function. The E-Link material is the same as the E-link material used in the Klassic HD® Acetabular Insert with E-Link Poly (K141972) and Pipeline's Vitamin E Poly (K112802).
### Substantial Equivalence:
Engineering analyses and bench testing were performed on E-Link® Knee Components to evaluate wear for the worst case E-Link® Knee Construct, tibial-femoral stability characteristics, stress distributions and range of motion and tibial modular disassembly characteristics, as well as patella-femoral resistance to lateral subluxation and surface stress distribution. The results of these analyses and testing indicate that the E-Link® Components are substantially equivalent to the predicate components. Knee Additionally, the E-Link® Knee Components are in compliance with LAL testing requirements for orthopedic implants.
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.
