K070928 · Plus Orthopedics AG · LZO · Aug 1, 2007 · Orthopedic
Device Facts
Record ID
K070928
Device Name
CERAMIC BALL HEADS, 28, 32 AND 36 MM
Applicant
Plus Orthopedics AG
Product Code
LZO · Orthopedic
Decision Date
Aug 1, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3353
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Please note that the patient should be skeletally mature and the patient's condition should be due to the following: 1. Osteoarthritis 2. Rheumatoid arthritis 3. Tumor conditions involving the upper third of the femur of the Acetabular 4. Ankylosing spondylitis 5. Psoriatic arthritis 6. Old osteomyelitis with a long infection-free period and a normal WBC. ESR and C-reactive protein 7. Non-union of femoral neck fracture or avascular necrosis of the femoral head 8. Post-traumatic fracture/dislocation of the hip 9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present 11. Revision of a previous unsuccessful osteotomy, Girdlestone resection, cup arthroplasty or hemi-arthroplasty. These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR-PLUS®, SL- PLUS® Lateral, Modular- PLUS® and IPM stem.
Device Story
Ceramic ball heads for mechanical fixation to specific Plus Orthopedics hip stems (SL-PLUS, SLR-PLUS, SL-PLUS Lateral, Modular-PLUS, IPM). Used in primary and revision total hip arthroplasty to restore hip motion and relieve pain. Operated by surgeons in clinical settings. Device acts as the femoral head component of a hip prosthesis. Benefits include structural restoration of the hip joint in patients with disease or trauma.
Clinical Evidence
Bench testing only. Compliance with ISO 6474:1994 (ceramic materials) and ISO 7206-10:2003 (hip-joint prostheses). Design verification and validation performed per 21 CFR 820.30.
Technological Characteristics
Material: BIOLOX® forte (high purity aluminum oxide per ISO 6474 with magnesium). Sizes: 28, 32, 36 mm. Sterilization: Radiation per ISO 11137. Mechanical fixation to proprietary hip stems.
Indications for Use
Indicated for skeletally mature patients requiring primary or revision total hip arthroplasty due to osteoarthritis, rheumatoid arthritis, tumor conditions, ankylosing spondylitis, psoriatic arthritis, old osteomyelitis, non-union of femoral neck fracture, avascular necrosis, post-traumatic fracture/dislocation, or revision of previous unsuccessful hip procedures (arthrodesis, arthroplasty, osteotomy).
Regulatory Classification
Identification
A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.
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K070928
AUG - 1 2007
## Premarket Notification 510(k) Summary
#### 1.0 Submitter Information
| Company Name | Plus Orthopedics AG |
|-------------------|------------------------------------------------------------------|
| Company Address | Erlenstraße 4a<br>CH-6343 Rotkreuz<br>Switzerland |
| Contact Name | Pamela J. Weagraff, Principal Consultant<br>Quintiles Consulting |
| Contact Address | 18 Bridie Lane<br>Norfolk, MA 02056 |
| Contact Telephone | 508-528-1745 |
| Contact Facsimile | 978-752-1225 |
| Contact E-mail | pamela.weagraff@quintiles.com |
#### 2.0 Date Prepared: June 8, 2007
#### 3.0 Name of Device
- 3.1 Device Name: Ceramic Ball Heads, various sizes
- 3.2 Common Name: Ceramic Ball Heads
- 3.3 Classification Name and Reference: Hip Joint Metal/Ceramic/Polymer Semi-constrained Cemented or Nonporous Uncemented Prosthesis, Title 21 CFR Part 888.3353
#### 4.0 Substantial Equivalence Claimed to Predicate Device
Portland Ceramic (BIOLOX® forte), K061564 Need to add CoCrMo taper predicate used with Portland
#### 5.0 Device Description
The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR- PLUS®, SL- PLUS® Lateral, Modular- PLUS® and IPM stem. Manufactured by CeramTec AG, the Ceramic Ball Heads are made of BIOLOX® forte, a high purity aluminum oxide per ISO 6474, with a small amount of magnesium to prevent grain growth. The Ceramic Ball Heads are available in various sizes from 28, 32 up to 36 mm, in small medium and large for each.
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#### 6.0 Indications for Use
The Plus Orthopedics AG Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Please note that the patient should be skeletally mature and the patient's condition should be due to the following:
- Osteoarthritis 1.
- Rheumatoid arthritis 2.
- Tumor conditions involving the upper third of the femur of the Acetabular 3.
- 4. Ankylosing spondylitis
- 5. Psoriatic arthritis
- Old osteomyelitis -- with a long infection-free period and a normal WBC. ESR and C-reactive 6. protein
- 7. Non-union of femoral neck fracture or avascular necrosis of the femoral head
- 8. Post-traumatic fracture/dislocation of the hip
- ರ್ Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling
- 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present
- 11. Revision of a previous unsuccessful osteotomy, Girdlestone resection, cup arthroplasty or hemi-arthroplasty.
These ceramic ball heads are to be used only with hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR-PLUS®, SL- PLUS® Lateral, Modular- PLUS® and IPM stem.
### 7.0 Predicate Device Comparison of Indications for Use / Intended Use and Technical Characteristics
The comparison of the Ceramic Ball Heads 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 FDA web site. The comparison considered technical characteristics and the indications for use / intended use.
#### 8.0 Performance Data
- 8.1 Performance Standards: no performance standards applicable to this device, Hip Joint Metal/Ceramic/Polymer Semi-constrained Cemented or Nonporous Uncemented Prosthesis, Title 21 CFR Part 888.3353; Product Code: LZO, have been adopted under Section 514 of the Food Drug and Cosmetic Act.
- 8.2 The Ceramic Ball Heads comply with the following FDA recognized standards:
- 8.2.1 ISO 6474:1994, Implants for surgery -- Ceramic materials based on high purity alumina
- 8.2.2 ISO 7206-10, 2003, Implants for surgery -- Partial and total hip-joint prostheses --Part 10
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- AAMI / ANSI / ISO 11137:1994, Sterilization of health care products Requirements 8.2.3 for validation and routine control -- radiation sterilization and ANSI/AAMI/ISO 11137:1994 (Amendment 1:2002).
- Performance Testing: Design verification and design validation, e.g., bench testing was 8.3 performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.
#### 9.0 Conclusion
The information and data provided in this 510(k) Premarket Notification establish that the Ceramic Ball Heads, various sizes, are substantially equivalent to the afore-mentioned predicate device with respect to indications for use/intended use, and technical characteristics.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three human profiles incorporated into its design. The profiles are arranged in a way that they form the body and wings of the bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2007
Plus Orthopedics AG % Ms. Pamela Weagraff Principal Consultant 18 Bridie Lane Norfolk, Massachusetts 02056
Re: K070928
Trade/Device Name: Ceramic Ball Heads, 28, 32 and 36 mm Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: March 30, 2007 Received: April 3, 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. Iisting 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
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Page 2 - Ms. Pamela Weagraff
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.
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Milkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# ODE Indications for Use Statement
### 510(k) Number (if known): K070928
### Device Name: Ceramic Ball Heads, 28, 32 and 36 mm
### Indications for Use:
The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Please note that the patient should be skeletally mature and the patient's condition should be due to the following:
- 1. Osteoarthritis
- Rheumatoid arthritis 2.
- Tumor conditions involving the upper third of the femur of the Acetabular 3.
- 4. Ankylosing spondylitis
- Psoriatic arthritis 5.
- Old osteomyelitis with a long infection-free period and a normal WBC. ESR and C-6. reactive protein
- 7. Non-union of femoral neck fracture or avascular necrosis of the femoral head
- 8. Post-traumatic fracture/dislocation of the hip
- Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or 9. where low back pain or knee pain is becoming disabling
- · 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present
- 11. Revision of a previous unsuccessful osteotomy, Girdlestone resection, cup arthroplasty or hemi-arthroplasty.
These ceramic ball heads are to be used only hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR- PLUS®, SL- PLUS® Lateral, Modular- PLUS® and IPM stem.
Prescription Use: ____________________________________________________________________________________________________________________________________________________________ AND/OR (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)
**Concurrence of CDRH, Office of Device Evaluation (ODE)**
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Indications for Use Statement
510(k) Number_
Page C-2 of C-2
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.
