K070278 · Plus Orthopedics AG · LPH · Apr 16, 2007 · Orthopedic
Device Facts
Record ID
K070278
Device Name
POLARCUP DUAL MOBILITY SYSTEM
Applicant
Plus Orthopedics AG
Product Code
LPH · Orthopedic
Decision Date
Apr 16, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3358
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The POLARCUP® Dual Mobility System is indicated for: . All forms of osteoarthritis . . Dislocation risks . Progressive loss of function of the hip joint as a result of a degenerative post-. traumatic or inflammatory / rheumatic destruction of the joint . . Femoral head necrosis . Proximal femoral fractures (especially femoral neck) . . Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement . The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.
Device Story
POLARCUP® Dual Mobility System is an acetabular hip prosthesis component; consists of a press-fit or cemented stainless steel shell and a UHMWPE liner. Liner retains femoral head and moves freely within shell to enhance stability and mobility. Used by orthopedic surgeons in clinical settings for hip arthroplasty. Shells available in multiple configurations (with/without pegs/flanges) and sizes; cortical screws and pegs provided for fixation. System compatible with standard CoCrMo, ceramic, or stainless steel ball heads and femoral stems. Device provides mechanical replacement of hip joint surface to restore function and reduce pain in patients with degenerative or traumatic hip conditions.
Clinical Evidence
No clinical data. Substantial equivalence established via bench testing and design verification per 21 CFR 820.30, confirming compliance with material and performance requirements.
Technological Characteristics
Materials: Wrought high nitrogen stainless steel (ISO 5832-9), unalloyed titanium (ISO 5832-2), stainless steel 316LVM (ISO 5832-1), UHMWPE (ISO 5834-2). Shells: 43-67mm diameter, grit-blasted titanium-coated or mirror-polished. Liner: UHMWPE, 22mm or 28mm internal diameter. Fixation: Cemented or press-fit with optional pegs/flanges. Sterilization: Radiation (ISO 11137).
Indications for Use
Indicated for skeletally mature individuals requiring hip joint rehabilitation due to osteoarthritis, dislocation risk, degenerative/post-traumatic/inflammatory/rheumatic joint destruction, femoral head necrosis, proximal femoral fractures, or failed prior hip surgeries.
Regulatory Classification
Identification
A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.
{0}------------------------------------------------
K070278
APR 16 2007
# D.0 Premarket Notification 510(k) Summary
#### D.1 Submitter Information
Company Name and Address:
PLUS ORTHOPEDICS AG Erlenstraße 4a CH-6343 Rotkreuz Switzerland
Contact Name:
Pamela J. Weagraff, Principal Consultant Quintiles Consulting 18 Bridie Lane Norfolk, MA 02056
Telephone: 508-528-1745 Facsimile: 978-752-1225 E-mail: pamela.weagraff@quintiles.com
Date Prepared: January 23, 2007
### D.2 Name of Device
- 2.1 Trade Name: POLARCUP® Dual Mobility System
- 2.2 Common Name: Acetabular Component
- 2.3 Classification Name and Reference:
Title 21 Code of Federal Regulation (CFR), Part 888.3358, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Product Code: LPH Title 21, CFR, Part 888.3390, Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis; Product Code: KWY
### Substantial Equivalence Claimed to Predicate Device D.3
Biomet® Tri-Polar Systems, K991990
Traditional 510(k) - POLARCUP® Dual Mobility System January 23, 2007
{1}------------------------------------------------
## D.4 Device Description
The POLARCUP® Dual Mobility System consists of two components: a thin press fit shell and a liner component.
#### 4.1 Shell Component
The POLARCUP® shell, is manufactured from stainless steel INOX M30NW according to ISO 5832-9:1992, Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel, and is available in three configurations:
- � Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, with pegs and two flanges, uncemented use: allows for implantation with no pegs and no flanges, with no pegs and contoured flanges, screws in flanges but with no pegs, and two impacted pegs and two screws in flanges
- . Stainless steel, grit-blasted with pure Titanium-coating, 15 to 20% porosity, without pegs and flanges, uncemented use)
- . Stainless steel, mirror polished, without pegs and flanges, cemented use
Note: the pure Titanium coating found in the uncemented versions is a Titanium alloy according to ISO 5832-2:1999. Implants for Surgery -Metallic Materials - Part 2: Unalloyed Titanium.
The POLARCUP® shell is available in 13 sizes for each of the titaniumcoated versions for uncemented use, ranging in diameter from 43 mm to 67 mm. The mirror-polished version for cemented use is available in 11 sizes, ranging in diameter from 43 mm to 63 mm.
### 4.2 Cortical Screws and Impacted Pegs
Cortical screws and impacted pegs, both made of stainless steel INOX 316LVM according to ISO 5832-1:1997, Implants for surgery -- Metallic materials -- Part 9: Wrought Stainless Steel, are available for use with the POLARCUP® shell version with pegs and flanges for uncemented use. The cortical screws are 4.5 mm in diameter and available in 6 different lengths ranging from 40 mm to 60 mm. The impacted pegs are available in a single length of 13 mm.
{2}------------------------------------------------
### 4.3 Liner Component
The POLARCUP® liner component is a polyethylene insert, specifically Ultra-High Molecular Weight Polyethylene (UHMW PE) according to ISO 5834-2:1998, Implants for Surgery -- Ultra-High-Molecular-Weight Polyethylene - Part 2 : Moulded Forms, that retains the femoral head and moves freely in the POLARCUP® shell, allowing increased mobility and stability. The liner component is available in two internal joint diameters. 22 mm and 28 mm. The 22 mm diameter liner is available in 13 different sizes of spherical external radius of curvature whereas the 28 mm diameter liner is available in 11 different sizes of spherical external radius of curvature (to ensure a minimal thickness of 6.5 mm according to EN 12563).
The POLARCUP® Dual Mobility System may be used with the following components provided that they are legally marketed in the US and meet these specifications:
- Ball Heads: made of CoCrMo, ceramic or stainless steel, with diameters . of 22 or 28 mm
- Femoral Stems: polished or electro-polished necks .
## D.5 Intended Use
The POLARCUP® Dual Mobility System is indicated for:
- . All forms of osteoarthritis
- . Dislocation risks
- Progressive loss of function of the hip joint as a result of a degenerative post-. traumatic or inflammatory / rheumatic destruction of the joint
- . Femoral head necrosis
- Proximal femoral fractures (especially femoral neck) .
- . Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement
The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.
# D.6 Predicate Device Comparison of Indications for Use / Intended Use and Technical Characteristics
The comparison of the POLARCUP® Dual Mobility System was based on a review of the Design Control documentation, relevant aspects of which are included in the company's 510(k) Premarket Notification, and information concerning the predicate device that was obtained from the predicate device manufacturer's web site. The comparison considered technical characteristics and the indications for use / intended use.
Traditional 510(k) - POLARCUP® Dual Mobility System January 23, 2007
{3}------------------------------------------------
## D.7 Performance Data
- 7.1 Performance Standards (Section 514 Compliance): no applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act, for either hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis or hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
- 7.2 The POLARCUP® Dual Mobility System does conform to the following FDA recognized standards:
### 7.2.1 Sterility
ISO 11137-1:2006, Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2, 2006, Sterilization of health care products --Radiation -- Part 2: Establishing the sterilization dose
#### 7.2.2 Materials
ISO 5832-9:1992, Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel
ISO 5832-2:1999, Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium
ISO 5832-1:1997, Implants for surgery -- Metallic materials -- Part 9: Wrought Stainless Steel
ISO 5834-2:1998, Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene - Part 2 : Moulded Forms
- 7.3 Performance Testing: Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.
## D.8 Conclusion:
The information and data provided in this 510(k) Premarket Notification establish that the POLARCUP® Dual Mobility System is substantially equivalent to the afore-mentioned predicate device with respect to indications for use/intended use, and technical characteristics.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Plus Orthopedics AG % Quintiles Consulting Ms. Pamela J. Weagraff, MBA, RAC 18 Bridie Lane Norfolk, Massachusetts 02056
APR 1 6 2007
Re: K070278
Trade/Device Name: POLARCUP® Dual Mobility System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, KWY Dated: January 23, 2007 Received: January 29, 2007
Dear Ms. Weagraff:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
{5}------------------------------------------------
### Page 2 - Ms. Pamela J. Weagraff
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Brye Kup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
# ODE Indications Statement
## 510(k) Number (if known): Unknown
Device Name: POLARCUP® Dual Mobility System
### Indications for Use:
The POLARCUP® Dual Mobility System is indicated for:
- All forms of osteoarthritis .
- Dislocation risks .
- Progressive loss of function of the hip joint as a result of a degenerative post-. traumatic or inflammatory / rheumatic destruction of the joint
- . Femoral head necrosis
- Proximal femoral fractures (especially femoral neck) .
- . Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement
The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.
Prescription Use: X (21 CFR 801 Subpart D) Over-the-Counter Use: (21 CFR 807 Subpart C)
# (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michale Buchman
Division Sign-up),
Division of Ger. vol. Restorative,
**and** A
**510**(k, ...K070278
Traditional 510(k) - POLARCUP® Dual Mobility System January 23, 2007
Company Confidential Page 9 of 77
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.
