The EVOLUTION® MP Adaptive PS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: - Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; - Inflammatory degenerative joint disease including rheumatoid arthritis; - Correction of functional deformity; - Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Total Knee System is for cemented use only.
Device Story
The EVOLUTION® MP Adaptive PS Tibial Insert is a prosthetic component for knee arthroplasty; it enables the use of a posterior stabilized femoral component from the EVOLUTION® MP Total Knee System with a tibial base from the ADVANCE® Knee System. The device is intended for cemented use only. It is manufactured from UHMWPE and is available in 7 sizes for left and right applications, with thicknesses ranging from 10-20mm. The device is used by orthopedic surgeons in a clinical/surgical setting. It functions as a mechanical interface to restore joint function and stability. Clinical benefit is derived from the correction of functional deformity and treatment of degenerative joint disease or fractures. Safety and effectiveness were established via engineering analyses comparing the device to predicate systems, confirming no new worst-case scenarios regarding static stability, contact area, wear, post strength, or range of motion.
Clinical Evidence
No clinical data was provided. The device was evaluated via engineering analyses for static stability, contact area, wear, post strength, and range of motion. These analyses determined the device does not present a new worst-case scenario compared to the predicate devices.
Technological Characteristics
Tibial insert manufactured from UHMWPE. Available in 7 sizes (left/right) with thicknesses from 10-20mm. Designed for cemented use. Mechanical device; no energy source or software components. Evaluated for static stability, contact area, wear, post strength, and range of motion.
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).
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word, there are three horizontal lines that appear to be stylized representations of wings or feathers. The overall design is simple and modern, with a focus on the typography and the graphic element beneath it.
### 510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLUTION® MP Adaptive PS Tibial Insert.
(a){1) Submitted By:
**OCT 2 3 2013**
Date:
Contact Person:
(a)(2) Proprietary Name of Modified Device:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc. 5677 Airline Rd Arlington, TN 38002 (901) 867-4146
June 7, 2013
Theresa Leister Regulatory Affairs Manager
EVOLUTION® MP Adaptive PS Tibial Insert
Tibial Base Insert
21 CFR 888.3560 Knee joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Class ニ
21 CFR 888.3530 Knee joint Femorotibial Metal/Polymer Semi-Constrained Cemented Prosthesis Class II
Subject Product Code and Panel Code:
(a)(3) Predicate Devices:
Orthopedics/87/ JWH, HRY
EVOLUTION® MP Total Knee System (K093552) EVOLUTION® MP Adaptive CS Insert (K113325)
## {a)(4) Device Description
The purpose of this submission is to introduce a new EVOLUTION® MP Adaptive PS Tibial Insert that allows use of a posterior stabilized femoral component from the EVOLUTION® MP Total Knee System with a tibial base from the ADVANCE® Knee System.
#### Headquarters
Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone www.wml.com
Page 1 of 2
{1}------------------------------------------------
EVOLUTION® MP Adaptive PS Tibial Insert Special 510(k) 510(k) Summary
Image /page/1/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic consisting of three horizontal lines that curve slightly upward, resembling a stylized wing or swoosh design. The overall impression is a logo or branding element, possibly for a company or product named Wright.
# (a)(5) Indications for Use
The EVOLUTION® MP Adaptive PS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, 1. or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis; 2.
- 3. Correction of functional deformity;
- 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Total Knee System is for cemented use only.
# (a)(6) Technological Characteristics of the Device
The indications for use of the EVOLUTION® Adaptive PS Tibial Insert are identical to the predicate devices. The lock detail of the EVOLUTION® Adaptive PS Tibial Insert is identical to that of the predicate EVOLUTION® Adaptive CS Tibial Insert. The design features are substantially equivalent to those of the predicate devices. The subject device allows use of a femoral component from the EVOLUTION® Total Knee System with a tibial base from the ADVANCE® Knee System. The design features of the EVOLUTION® Adaptive CS Insert are summarized below:
- � Tibial inserts manufactured from UHMWPE
- . Available in 7 sizes, left and right
- Tibial insert thickness: 10 20mm .
The EVOLUTION® Adaptive PS Insert was evaluated via engineering analyses for static stability, contact area, wear, post strength, and range of motion. The analysis determined that the subject device does not present a new worst case as compared to the predicate devices; therefore, no additional testing was performed.
# (b)(1) Nonclinical Testing
Nonclinical testing was not provided for the subject devices.
# (b)(2) Clinical Testing
Clinical data was not provided for the subject devices.
# (b)(3) Conclusions
The indications for use of the EVOLUTION® Adaptive PS Tibial Insert are identical to the predicate devices. The design features are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the EVOLUTION® MP Adaptive PS Insert are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification submission.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2013
Wright Medical Technology, Incorporated Ms. Theresa Leister Regulatory Affairs Manager 5677 Airline Road Arlington, Tennessee 38002
Re: K131679
Trade/Device Name: EVOLUTION® MP Adaptive PS Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, HRY Dated: September 23, 2013 Received: September 25, 2013
Dear Ms. Leister:
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 (reporting of medical device-related adverse events) (21
{3}------------------------------------------------
Page 2 - Ms. Theresa Leister
CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
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) 796-7100 or at its Internet address
for
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/3/Picture/6 description: The image shows the name "Erin Keith" in a stylized font. The letters are bold and black, with a unique design that makes them stand out. The name is written in a clear and legible manner, making it easy to read.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
# Indications for Use
510(k) Number (if known): K131679
Device Name: EVOLUTION® MP Adaptive PS Insert
Indications For Use:
The EVOLUTION® MP Adaptive PS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis; 2.
- mi Correction of functional deformity;
- 4. 'Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Total Knee System is for cemented use only.
Prescription Use X (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)
Casey L. Hanley, Ph.D
Division of Orthopedic Devices
Page 1 of 1
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.
