K042515 · Smith & Nephew, Inc. · JWH · Mar 14, 2005 · Orthopedic
Device Facts
Record ID
K042515
Device Name
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
Applicant
Smith & Nephew, Inc.
Product Code
JWH · Orthopedic
Decision Date
Mar 14, 2005
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 888.3560
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. High Performance Knee components are indicated for use only with cement and are single use devices.
Device Story
High Performance Knee is a total knee prosthesis system comprising femoral, tibial insert, and patellar components; designed for use with existing Genesis II tibial trays. System enables greater flexion range for patients with anatomical capability. Intended for surgical implantation by orthopedic surgeons in hospital settings. Device functions as a semi-constrained, cemented, polymer/metal/polymer prosthesis to replace knee joint surfaces. Benefits include restoration of joint function and increased range of motion in patients with degenerative or inflammatory joint disease. Single-use device.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by mechanical test data demonstrating the device is equivalent to currently used clinical devices and capable of withstanding expected in vivo loading.
Technological Characteristics
Semi-constrained, cemented, polymer/metal/polymer knee prosthesis. Components include femoral, tibial insert, and patellar parts. Designed for use with Genesis II tibial trays. Single-use.
Indications for Use
Indicated for patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis requiring primary or revision total knee replacement, specifically those with absent/incompetent anterior and posterior cruciate ligaments and intact collateral ligaments. Suitable for older patients with compatible age, weight, and activity levels. Contraindicated for non-cemented use.
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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KC42515
## Smith & Nephew, Inc. Summary of Safety and Effectiveness High Performance Knee
MAR 1 : 2005
## Contact Person and Address
Date of Summary: September 15, 2004
Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 (901) 399-5153
Name of Device: High Performance Knee Common Name: Knee prosthesis
## Device Description
The High Performance Knee consists of femoral, tibial insert and patellar components to be used with existing Genesis II tibial trays. The High Performance Knee is a total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range.
#### Device Classification
21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis - Class II
#### Mechanical and Clinical Data
A review of the mechanical test data indicated that the High Performance Knee is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.
## Indications for Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. High Performance Knee components are indicated for use only with cement and are single use devices.
#### Substantial Equivalence Information
The substantial equivalence of the High Performance Knee is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices -- Smith & Nephew Genesis II Knee System and Genesis II & Profix Zirconium Femoral Knee Components (K951987 and K962557, respectively) and the Zimmer NexGen Complete Knee Solution LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991581).
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Image /page/1/Picture/1 description: The image is a black and white logo. The logo features a stylized bird in flight, with three curved lines representing its wings and a wavy line representing its body. The bird is enclosed within a circular border. The text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the top and bottom of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR I 스 2005
Ms. Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
Re: K042515
Trade/Device Name: High Performance Knee Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis
Regulatory Class: II Product Codes: JWH Dated: March 1, 2005 Received: March 2, 2005
Dear Ms. Akil:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(t) promotion is substantially equivalent (for the indications felerenced above and nave determined be and marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1970, the encordance with the provisions of the Federal Food. Drug, devices that have occh recatissimed in assess approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvince of the general controls provisions of the Act. The Tou may, mercetore, market the do received been contrements for annual registration, listing of general controls provisions of aactice, 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 n your device is classified (boo abor of this. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations Inay be subject to suen additional seculations, Title 21, Parts 800 to 898. In addition, FDA may ou round in the overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that 1 Dr 3 issuanted or a subside complies with other requirements of the Act that I DA has made a acterimialisions administered by other Federal agencies. You must of any I catal statutes and regulations and admited to: registration and listing (21
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# Page 2 – Ms. Janet Johnson Akil
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as services also a CFR Part 807), fabeing (21 CFR Part 800); and if applicable, the clectronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 manening your and equivalence of your device to a legally premarket notheadon. The IDA miding of Sassamal repair 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 advice for your acc (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Comphanes at (210) 21 (21CFR Part 807.97). You may obtain Wilsoranding by reference to premainsmonitibilities under the Act from the Division of Small biller geleral information on Jour response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octisal http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark A. Millman
Miriam Provost, Ph.D. Acting 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
| 510(k) Number (if known): | K042515 |
|---------------------------|---------|
|---------------------------|---------|
Device Name: High Performance Knee
Indications for Use:
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, Total knee components are mated for mean assessments whose age, weight, and activity level are osteoarminis, or degeneralite in elast particles, unicompartmental replacement, compatible with an docquate tong term stabilized knee systems are designed for use in patients in or total knee replacement. Tootener the anterior and posterior cruciate ligaments are absent or phitrially and revision surger); whole ints remain intact. Smith & Nephew, Inc. High Performance incompetent and the sondicated for use only with cement and are single use devices.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Rectorative,
and Neurological Devic...s
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510(k) Number- K042515
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.
