K122183 · United Orthopedic Corp. · JWH · Feb 5, 2013 · Orthopedic
Device Facts
Record ID
K122183
Device Name
AUGMENT AND SCREW, PSA TYPE
Applicant
United Orthopedic Corp.
Product Code
JWH · Orthopedic
Decision Date
Feb 5, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3560
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws. Note: In the US, this device is for cemented use only.
Device Story
Augment and Screw, PSA Type, consists of femoral (distal) and tibial augments designed to extend the UNITED U2 Total Knee System - PSA Type. Femoral augments (Co-Cr-Mo alloy) and tibial augments (Ti-6Al-4V alloy) attach to existing femoral components and tibial baseplates via fixation screws. The entire implant construct is fixed with bone cement. Used in orthopedic surgery to address inadequate bone stock or soft tissue imbalance requiring increased tibiofemoral stabilization. Augments are sized to match specific U2 PSA components. Device provides structural support to the knee prosthesis, aiding in joint reconstruction and patient mobility.
Clinical Evidence
Bench testing only. Locking strength evaluation between femoral/tibial components and their respective augments was performed to ensure design integrity and substantial equivalence to predicate devices.
Technological Characteristics
Femoral augments: Co-Cr-Mo alloy (ASTM F75 or ASTM F1537). Tibial augments: Ti-6Al-4V alloy (ASTM F136/ISO 5832-3). Fixation: Screw-based attachment to components, cemented to bone. Sizes: 6 sizes (#1-6) matching U2 PSA components. Sterilization: Not specified.
Indications for Use
Indicated for skeletally mature patients undergoing knee arthroplasty with severe pain/disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, pseudogout, or posttraumatic joint loss. Includes patients with patellofemoral erosion, dysfunction, prior patellectomy, or moderate valgus/varus/flexion contraction. Indicated for patients requiring augmentation/stem extensions due to inadequate bone stock or increased stabilization for soft tissue imbalance.
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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K122183
# Augment and Screw, PSA Type
. 510(k) Summary
## 510(k) Summary of Safety and Effectiveness
| Submitted by: | United Orthopedic Corporation |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan |
| Phone Number: | +886-3-5773351 ext. 2212 |
| Fax Number: | +886-3-5777156 |
| Date of Summary: | July 20, 2012 |
| Contact Person | Fang-Yuan Ho<br>Regulation and Document Management |
| Proprietary Name: | Augment and Screw, PSA Type |
| Common Name: | Knee System Augments |
| Device Classification | Knee joint patellofemorotibial polymer/metal/polymer |
| Name and Reference: | semi-constrained cemented prosthesis per 21CFR 888.3560<br>This falls under the Orthopedics panel. |
| Device Class | Class II |
| Panel Code | Orthopaedics Device |
| Device Product Code: | JWH |
| Predicate Device: | 1. "UNITED" U2 Total Knee System - PSA Type (K082424)<br>2. "Zimmer" NexGen Complete Knee Solution Legacy CCK Type (K960279)<br>3. "BIOMET" Vanguard 360 Revision Knee System |
(K093293)
### Device Description:
"UNITED" Augment and Screw - PSA Type, including femoral augments - distal only and tibial augments, is an extension of cleared "UNITED" U2 Total Knee System -PSA Type (K082424). The raw materials, safety and effectiveness of this subject device
Page: Summary-1/3
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K122183
## Augment and Screw, PSA Type
510(k) Summary
are identical to the "UNITED" U2 Total Knee System - PSA Type (K082424), except for increasing their thickness and modifying the shape to mimic anatomy.
Femoral augment - distal only made of Co-Cr-Mo alloy (ASTM F75 or ASTM F1537) are available in 12 mm and 16 mm thickness and can be positioned on either side of femoral component. This component is only available distally. Tibial augments are made of Ti-6Al-4V alloy (ASTM F136/ISO 5832-3) and with 15 mm thickness. The periphery of the distal end of tibial augments is larger than that of the proximal end. It is left/right specific. The femoral augments and tibial augments are sized to match the femoral components and tibial base plates, respectively. There are 6 sizes (sizes #1 through 6) to match the corresponding augmentable femoral components - PSA type and tibial baseplates - PSA type (K082424). The augments are affixed to the tibial and femoral components with screw fixation and that the implant construct as a whole is to be fixed with cement. This device should not be used with another manufacturer's total knee systems since dimensional compatibility cannot be assured. It also should not be used with U2 Total Knee System - PS Type and CR Type. For total knee replacement, "UNITED" patella components (K021657, K051640, K082469, and K103733) are intended to be used with U2 Total Knee System - PSA Type (K082424) and the subject device.
#### Indications
This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate
UOC-FDA-023
Page: Summary-2/3
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#### ತಿ Augment and Screw, PSA Type
510(k) Summary
valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
Note: In the US, this device is for cemented use only.
#### Basis for Substantial Equivalence:
The intended uses, materials, locking mechanism design and sterilization method of femoral augments - distal only are similar to the femoral augments of U2 Total Knee System - PSA Type (K082424) and "Zimmer" NexGen Complete Knee Solution Legacy CCK Type (K960279). The differences between these three devices are 1) thickness, 2) geometry, and 3) the femoral screw length and its threaded length.
The intended uses, substrate materials, locking mechanism design and sterilization method of tibial augments are similar to the tibial augments of U2 Total Knee System -PSA Type (K082424) and "BIOMET" Vanguard 360 Revision Knee System (K093293). The differences between these three devices are 1) thickness, 2) geometry, and 3) edge taper.
#### Performance Data:
The locking strength evaluation between femoral component and femoral augment, as well as tibial baseplate and tibial augment completed as part of the design assurance process, demonstrated that this device is substantially equivalent to the predicate device.
Page: Summary-3/3
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Letter dated: February 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
United Orthopedic Corporation % Ms. Fang-Yuan Ho Regulatory Affairs, Manager No. 57, Park Avenue 2, Science Park Hsinchu, 300 Taiwan
Re: K122183
Trade/Device Name: Augment and Screw, PSA Type Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 20, 2012 Received: December 26, 2012
Dear Ms. Ho:
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
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#### Page 2 - Ms. Fang-Yuan Ho
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
# Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indication for Use
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: Augment and Screw, PSA Type
#### Indications for Use:
This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
Note: In the US, this device is for cemented use only.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Anton E. Dmitriev, PhD | 2013.02.05 10:03:47 |
|--------------------------------|---------------------|
| Division of Orthopedic Devices | -05'00' |
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.
