SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
K080330 · Biomet, Inc. · KRO · Jun 11, 2008 · Orthopedic
Device Facts
Record ID
K080330
Device Name
SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
Applicant
Biomet, Inc.
Product Code
KRO · Orthopedic
Decision Date
Jun 11, 2008
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3510
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Biomet's Segmental Distal Femoral Components are intended for use in total knee replacement and the Proximal Femoral Bodies are intended for use in hip replacement procedures. Specific indications for these devices are: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis. 2. Correction of varus, valgus or post traumatic deformity 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 4. Ligament deficiencies 5. Tumor resections 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques 7. Revision of previously failed total joint arthroplasty 8. Trauma These devices are to be used with bone cement unless a proximal femur is indicated for use (USA) When used with Biomet's Compress® Segmental Femoral Replacement System, the indications for use are uncemented application in cases of: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma.
Device Story
Segmental distal femoral components and proximal femoral bodies; designed for orthopedic reconstruction of femur. Features integrated female taper bore for direct connection to Compress® spindle; eliminates need for separate taper adapter; enables shorter resection lengths. Used in clinical settings by orthopedic surgeons during hip or knee replacement/salvage procedures. Components replace articulating surfaces of femur; provide structural support in tumor resection or revision cases. Device integrates into existing Biomet Compress® Segmental Femoral and Orthopedic Salvage Systems. Clinical benefit includes restoration of joint function and structural integrity in complex orthopedic cases.
Clinical Evidence
No clinical data provided as a basis for substantial equivalence. Bench testing only.
Technological Characteristics
Orthopedic femoral replacement components; features female taper bore for direct spindle connection. Materials and design are consistent with predicate femoral replacement systems. Intended for cemented use or uncemented application when used with the Compress® System.
Indications for Use
Indicated for patients requiring hip or knee joint replacement due to avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis, deformity (varus/valgus/post-traumatic), ligament deficiency, tumor resection, non-unions, femoral neck/trochanteric fractures, or revision of failed arthroplasty/osteotomy/arthrodesis. Used with bone cement or uncemented with Compress® System.
Regulatory Classification
Identification
A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Predicate Devices
Compress® Segmental Femoral Replacement System (K043547 & K062998)
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Image /page/0/Picture/1 description: The image shows the logo for BIOMET ORTHOPEDICS, INC. The word "BIOMET" is in a stylized font with a geometric design. Below the logo, the words "ORTHOPEDICS, INC." are printed in a simple, sans-serif font. The logo appears to be for a company that specializes in orthopedic products or services.
510(k) Summary
JUN 11 2008
March 31, 2008 Preparation Date:
Biomet Manufacturing Corp. Applicant/Sponsor:
Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist
Proprietary Name: Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress® Female Taper
Common Name: Proximal or distal femoral replacement components
### Classification Names:
- · Hip Joint. Metal/Polymer, Semi-Constrained, Cemented Prosthesis (21 CFR §888.3350)
- · Knee Joint, Femorotibial, Metal/Polymer Constrained, Cemented Prosthesis (21 CFR \$888.3510)
### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- · Compress® Segmental Femoral Replacement System K043547 & K062998
- · Orthopedic Salvage System (OSS™) K002757& K052685
#### Device Description:
The Segmental Distal Femoral Components with a Compress® Female Taper are designed to replace the distal end of the femur including the knee articulating surface. The Proximal Femoral Bodies with a Compress® Female Taper are designed to replace the proximal end of the femur including the hip articulating surface. These components are intended for use with Biomet's Compress® Segmental Femoral and Orthopedic Salvage Systems. The new devices that are the subject of this 510(k) have a taper bore that is directly compatible with the taper of the Compress spindle eliminating the need for a taper adapter and allowing for smaller resection lengths.
#### Intended Use:
Biomet's Segmental Distal Femoral Components are intended for use in total knee replacement and the Proximal Femoral Bodies are intended for use in hip replacement procedures. Specific indications for these devices are:
- 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.
- 2. Correction of varus, valgus or post traumatic deformity
- 3. Correction of revision of unsuccessful ostectorny, arthrodesis, or previous joint replacement.
- 4. Ligament deficiencies
Mailing Address Warson 0 16581-0587 Toll Free: 820,348,9500
Shipping Address East Bel Drive Warsan N 46582
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#### 510(k) Summary
5 North Gammery
Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress® Female Taper March 31, 2008
- 5. Tumor resections
- 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
- 7. Revision of previously failed total joint arthroplasty
- 8. Trauma
These devices are to be used with bone cement unless a proximal femur is indicated for use (USA)
When used with Biomet's Compress® Segmental Femoral Replacement System, the indications for use are uncemented application in cases of:
- 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- 2. Tumor resections.
- 3. Revision of previously failed total joint arthroplasty.
- 4. Trauma.
Summary of Technologies: The Segmental Distal Femoral Components and Proximal Femoral Bodies with Compress® Female Taper have similar technologies as the predicate devices.
Non-Clinical Testing: None provided as a basis for substantial equivalence.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks of property of Biomet, Inc.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2008
Biomet, Inc. % Ms. Patricia Sandborn Beres Senior Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K080330
Trade/Device Name: Segmental Distal Femoral Components and Proximal Femoral Bodies with Compress® Female Taper Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulation Class: Class II Product Code: KRO, JDI Dated: June 3, 2008 Received: June 6, 2008
Dear Ms. Beres:
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
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Page 2 - Ms. Patricia Sandborn Beres
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240)- 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240)- 276-3464. 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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millerson
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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# Indications for Use
510(k) Number (if known): K080330
## Device Name: Segmental Distal Femoral Components and Proximal Femoral Bodies with Compress® Female Tapers
Biomet's Segmental Distal Femoral Components are intended for use in total knee replacement and the Proximal Femoral Bodies are intended for use in hip replacement procedures. Specific indications for these devices are:
- 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.
- 2. Correction of varus, valgus or post traumatic deformity
- 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- 4. Ligament deficiencies
- 5. Tumor resections
- 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
- 7. Revision of previously failed total joint arthroplasty
- 8. Trauma
These devices are to be used with bone cement unless a proximal femur is indicated for use (USA)
When used with Biomet's Compress Segmental Femoral Replacement System, the indications for use are uncemented application in cases of:
- 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous ioint replacement.
- 2. Tumor resections.
- 3. Revision of previously failed total joint arthroplasty.
- 4. Trauma.
Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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)
NetRp dyler formxm
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K080330
4-1
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Part 1 — Search, results, and everyday workflows 16 min
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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.
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You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
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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.
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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.
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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.
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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.
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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.
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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.
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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.
