(225 days)
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a segmental femoral replacement system intended to correct or revise unsuccessful osteotomy, arthrodesis, previous joint replacement, tumor resections, and trauma, which are all conditions requiring therapeutic intervention.
No
The device description and indications for use clearly describe a surgical implant used for revision of previous joint replacements, tumor resections, or severe trauma, not for diagnosing conditions.
No
The device description clearly outlines physical components (anchor plug, spindle assembly, intercalary segment) that are implanted in the femur, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description clearly states that this is a surgical implant system (Compress Segmental Femoral Replacement System) intended for use in the femur to address issues like failed osteotomies, tumor resections, and trauma. It is a physical device implanted within the body.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples or providing diagnostic information about a patient's condition. Its purpose is to mechanically replace or support bone segments.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Indications:
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Tumor resections.
- Revision of previously failed total joint arthroplasty
- Trauma
The ComPreSs Segmental Femoral Replacement System components are intended for uncemented use only.
Product codes
JDL, KWA, KRO, KWZ, JDI, LZO, MEH, LPH, LZY, KWY
Device Description
The ComPreSs® Segmental Femoral Replacement System consists of three main components, the anchor plug, the spindle assembly, and the intercalary segment. The Anchor Plug is embedded within the medullary canal, the Spindle Assembly attaches to the Anchor Plug and is compressed against the bone / implant interface at the osteotomy site. The Intercalary Segment attaches to the Spindle Assembly, and completes the Femoral Stem Component.
This system is intended for use in both the proximal and distal femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal and distal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: The engineering rationale with the attached literature and mechanical test reports support the claim for substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing in support of the predicate Compress® Distal Femoral Replacement System is sufficient to ensure safety and efficacy. No further clinical testing is necessary to support the claim for substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031804, K041352, K002757, K952970, K972401
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
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).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
AUG 5 - 2005
AUG 5 - 2005 K043547
Image /page/0/Picture/3 description: The image shows the word "BIOMET" in a stylized, bold font. The letters are white with a thick black outline. The "O" in the word is a perfect circle, and the "E" and "T" have a unique, blocky design.
510(k) Summary
| Applicant/Sponsor: | Biomet Manufacturing Corp.
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Baker
Biomet Manufacturing Corp.
P.O. Box 587
Warsaw, Indiana 46581-0587
Phone: (574) 267-6639
FAX: (574) 372-1683 |
| Proprietary Name: | ComPreSs® Segmental Femoral Replacement System |
| Common or Usual Name: | Segmental Femoral Stem Component. |
| Classification Name: | Hip joint metal/metal semi-constrained, with a cemented acetabular component,
prosthesis (21 CFR §888.3320)
Hip joint metal/metal semi-constrained, with an uncemented acetabular
component, prosthesis (21 CFR §888.3330)
Knee Joint, Femorotibial, Metal/Polymer Constrained, Cemented Prosthesis (21
CFR §8883510).
The Compress® Proximal Femoral components, compatible shells, heads, and
liners included in this submission have the following classifications:
- Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR §888.3310)
- Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR §888.3350)
- Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353)
- Hip joint metal/polymer/metal semi-constrained, porous-coated, uncemented prosthesis (21 CFR §888.3358)
- Hip joint (hemi-hip) acetabular metal cemented prosthesis (21 CFR §888.3370)
- Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR §888.3390) |
Device Product Codes: JDL, KWA, KRO, KWZ, JDI, LZO, MEH, LPH, LZY and KWY.
126
MAILING ADDRESS
P.O. Box 587
Warsaw, IN 46581-0587
SHIPPING ADDRESS
56 E. Bell Drive
Warsaw, IN 46582
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1
2/2
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
ComPreSs® Distal Femoral Replacement System - Biomet Inc. (K031804, K041352) Orthopedic Salvage System (OSS) - Biomet Inc. (K002757) Modular Replacement System (MRS) - Howmedica (K952970, K972401)
Device Description:
The ComPreSs® Segmental Femoral Replacement System consists of three main components, the anchor plug, the spindle assembly, and the intercalary segment. The Anchor Plug is embedded within the medullary canal, the Spindle Assembly attaches to the Anchor Plug and is compressed against the bone / implant interface at the osteotomy site. The Intercalary Segment attaches to the Spindle Assembly, and completes the Femoral Stem Component.
This system is intended for use in both the proximal and distal femur.
Intended Use:
Indications:
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
-
- Revision of previously failed total joint arthroplasty
-
- Trauma
The ComPreSs* Segmental Femoral Replacement System components are intended for uncemented use only.
Summary of Technologies: All components of this system are identical in material, processing, function, and design to their respective predicate components.
Non-clinical Testing: The engineering rationale with the attached literature and mechanical test reports support the claim for substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing in support of the predicate Compress® Distal Femoral Replacement System is sufficient to ensure safety and efficacy. No further clinical testing is necessary to support the claim for substantial equivalence to the predicate devices.
All trademarks are property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, conveying the organization's focus on health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 23 2009
Biomet Manufacturing Corp. % Mr. Gary Baker Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46581-0587
Re: K043547
Trade/Device Name: Compress Segmental Femoral Replacement System Regulation Number: 21 CFR 888.3320 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA, JDL, KRO, KWZ, JDI, LZO, MEH, LPH, KWY Dated: July 25, 2005 Received: July 26, 2005
Dear Mr. Baker:
This letter corrects our substantially equivalent letter of August 5, 2005.
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 (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 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
3
Page 2 - Mr. Gary Baker
limited to: registration and listing (21 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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
Chardan Ruenup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page I of I
Statement of Indications For Use
510(k) Number (IF KNOWN): _KO43547
Device Name: Compress Segmental Femoral Replacement System
Indications for Use:
Indications:
-
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
Tumor resections.
-
Revision of previously failed total joint arthroplasty
-
Trauma
・・
The Compress Segmental Femoral Replacement System components are intended for uncemented use only.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (Per 21 CFR 807 Subpart C)
LEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pavlovich
Division Sign-Restorative, Division of Gene and Neurological
510(k) Number K043547