K052888 · Biomet Manufacturing Corp · KWA · Dec 6, 2005 · Orthopedic
Device Facts
Record ID
K052888
Device Name
POROUS TITANIUM ACETABULAR AUGMENTS
Applicant
Biomet Manufacturing Corp
Product Code
KWA · Orthopedic
Decision Date
Dec 6, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3330
Device Class
Class 3
Attributes
Therapeutic
Indications for Use
The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies. The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use. The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.
Device Story
Porous Titanium Acetabular Augments serve as prosthetic alternatives to structural allograft for segmental deficiencies in hip arthroplasty. Constructed from porous titanium alloy, these augments feature screw holes for 6.5 mm bone screws to facilitate adjunct fixation to native bone. The augment is affixed to the mating acetabular cup using bone cement; the resulting construct is used in either cemented or uncemented hip procedures. Used by orthopedic surgeons in clinical settings, the device addresses bone loss, providing structural support to improve implant stability and patient outcomes in primary or revision hip surgeries.
Clinical Evidence
No clinical data provided; substantial equivalence based on non-clinical laboratory testing.
Technological Characteristics
Constructed of porous titanium alloy conforming to ASTM F 1580-95. Features include screw holes for 6.5 mm bone screws. Available in outer diameters from 48 mm to 58 mm in 2 mm increments, with three subsizes (small, medium, large) per diameter. Mechanical fixation via bone cement to acetabular cup.
Indications for Use
Indicated for skeletally mature individuals undergoing primary or secondary revision hip arthroplasty for noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or treatment of non-union, femoral neck, or trochanteric fractures of the proximal femur with head involvement unmanageable by other techniques.
Regulatory Classification
Identification
A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).
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K05>888 pgx '14
## DEC 6 2005
## 510(k) Summary
Applicant/Sponsor: Biomet Manufacturing Corp.
Allison Koskey Contact Person:
Proprietary Name: Porous Titanium Acetabular Augments
Common Name: Acetabular augments
Classification Name: Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous Uncemented (888.3358); Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented (888.3350); Hip joint metal/polymer constrained cemented or uncemented prosthesis (888.3310); Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis (888.3320); Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (888.3330); Hip joint metal/ceramic/polymer semi-constrained cemented or non porous uncemented prosthesis (888.3353)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Hedrocel® Acetabular Augment (K001471)
Device Description: The acetabular augments are constructed of porous titanium alloy conforming to ASTM F 1580-95. The augments range in outer diameter size from 48 mm to 58 mm in 2 mm increments. Each outer diameter will have three subsizes; small, medium, and large. The Porous Titanium Acetabular Augments incorporate screw holes that allow for the use of 6.5 mm bone screws, for adjunct fixation of the acetabular component and the native bone.
Intended Use: The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of:
- 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- 5. Revision of previously failed total hip arthroplasty.
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The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies.
The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use.
The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.
Summary of Technologies: The technological characteristics (material modification, design, sizing, indications) of the Porous Titanium Acetabular Augments are similar to or identical to the predicate device.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc. except for Hedrocel®, which is property of Zimmer Holdings
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 6 2005
Allison Koskey Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K052888
K052860
Trade/Device Name: Porous Titanium Acetabular Augments Regulation Number: 21 CFR 888.3320 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prostheses Regulatory Class: III Regulatory Class: In
Product Codes: KWA, JDI, JDL, KWZ, LPH, LZO, MAY, MEH Dated: October 10, 2005 Received: October 13, 2005
Dear Ms. Koskey:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and nave delemined the active are devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device Amendments for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug commerce prior to May 28, 1970, the chaculence with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance whiles approval application (IPMA).
and Cosmetic Act (Act) that do not require approval as provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to tire genirements for annual registration, listing of
general controls provisions of the Act include requirements for and general controls provisions of the receiners required required in the branding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it can If your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Time A. B.A. In oddition FTA m may be subject to such additional controlist Existing major osyon to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarations, our device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuales of a substition on the requirements of the Act
that FDA has made a determination that your device coderal groppies. You must that FDA has made a determination inal your areas by other Federal agencies. You must or any Federal statutes and regilantons annimaling, but limited to: registration and listing (21
comply with all the Act's requirements, including, but him and isats as set comply with all the Act S requirements, merasms, manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if emplicable, the electronic CFR Part 807); labeling (21 CFR Fall on (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and if applicable, forth in the quanty systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1
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## Page 2- Allison Koskey
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin makemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, per premarket notification. The PDA intuing of substanted by 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
r the recultive and the same of the said to the regulation entitled If you desire specific advice for your ac 110 concerner and and the regulation entitled. contact the Office of Compliance at (301) 99 - 100.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Partha Division of Small "Misbranding by reference to premants noufficalson of Sct from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or 2010)
Manufacturers, International and Consumer Assistance of Virginator viruspotvinde Manufacturers, International and Consumer > Ibolicanoo a rovedrh/industry/suppoty/index.html.
Sincerely yours,
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known):
Device Name: Porous Titanium Acetabular Augments
Indications For Use:
The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of:
- 1 . Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- 5. Revision of previously failed total hip arthroplasty.
The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies.
The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use.
The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
AND/OR (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)
Q.83
(Division Sign-Off) Division of Ceneral, Rostorative,
Page 1 of 1
**and Neurological Devices**
**510(k) Number** K052889
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.
