(139 days)
No
The device description and intended use are purely mechanical, describing a physical implant for hip replacement. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is a prosthetic implant (hip joint replacement), which is a medical device, but its primary function is mechanical replacement rather than direct therapeutic intervention like drug delivery or physiotherapy.
No
Explanation: The device described is a medical implant designed to replace a hip joint, which is a therapeutic function, not a diagnostic one. It is used to treat patients with hip dislocation issues.
No
The device description clearly details physical components made of UHMWPE and titanium alloy, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "replace a hip joint." This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical implantable device made of UHMWPE and titanium alloy, designed to be surgically placed in the hip joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
This device is clearly a surgical implant intended for orthopedic use.
N/A
Intended Use / Indications for Use
The FMP Constrained Liner is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Product codes (comma separated list FDA assigned to the subject device)
KWZ
Device Description
The constrained liner is first snapped into the shell and a ridge or lip around the outside of the liner engages a groove on the inside of the shell to provide a positive lock. The femoral head is inserted into the constrained liner and the locking ring secures the head into the liner.
The Constrained Liner consists of an UHMWPE insert conforming to ASTM F648 and a titanium alloy locking ring conforming to ASTM F620. The ID of the liners is 28 mm and the minimum thickness of the insert is 6 mm. The constrained liner is to be used in conjunction with the acetabular shells previously cleared in K973199, K974093, and K974095.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
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)
Risk Analysis:
Identified Risk: Infection - Mitigation Measures: Implants sold as sterile devices - Acceptance Criteria: Must provide a SAL of 10-6 - Results of Mitigation: See Sterility below. - Acceptance Criteria Met: YES
Identified Risk: Adverse Tissue Reaction - Mitigation Measures: Establish material and performance characteristics - Acceptance Criteria: Must meet the following standards: ASTM F136-98, ASTM F620-00, ASTM F648-00 - Results of Mitigation: See Standards Conformity below. - Acceptance Criteria Met: YES
Identified Risk: Pain and/or loss of function - Mitigation Measures: Establish material and performance characteristics - Acceptance Criteria: Must meet the following standards: ASTM F136-98, ASTM F620-00, ASTM F648-00 - Results of Mitigation: See Standards Conformity below. - Acceptance Criteria Met: YES
Identified Risk: Revision - Mitigation Measures: Include precautions and intended use on labeling and package inserts. Establish material and performance characteristics - Acceptance Criteria: Must include the precautions and intended use provided in the guidance document. Must meet the following standards: ASTM F136-98, ASTM F620-00 - Results of Mitigation: See Labeling below and Intended Use above. See Standards Conformity below. - Acceptance Criteria Met: YES
Identified Risk: Revision - Mitigation Measures: Include precautions and intended use on labeling and package inserts. - Acceptance Criteria: ASTM F648-00. Must include the precautions and intended use provided in the guidance document. - Results of Mitigation: See Labeling below and Intended Use above. - Acceptance Criteria Met: YES
Identified Risk: Device disassembly - Mitigation Measures: Femoral head lever-out testing - Acceptance Criteria: Must meet or exceed the lever-out forces for Encore bipolar acetabulum - Results of Mitigation: Testing was performed to show lever out mode exceeds those of the bipolar. - Acceptance Criteria Met: YES
Sterility: All components are supplied sterile in triple sealed containers maintaining double sterile barriers. A combination of pouches and/or trays is used to provide the operating room staff with easy handling of the components. One hundred per cent visual examination of the package seals is performed and recorded. Sterilization is accomplished using gamma radiation (minimum 25 kGy) and is verified by dose validation per ANSVAAMI/ ISO11137-94 and EN552 to achieve a sterility assurance level of 10-6. In addition, B. pumilus biological indicators (population 100) are utilized as a secondary verification. No testing is performed to determine if these parts are pyrogen free. Resterilization of components using autoclave steam cycle is prohibited.
Standards Conformity: As required by the risk analysis, performance characteristics for all materials used in manufacturing the components of the FMP Constrained Liner meet one of the following material standards:
- ASTM F136-98. "Standard specification for wrought Titanium-6 Vanadium ELI alloy for surgical implant applications"
- ASTM F620-00, "Standards specification for Titanium-6 Vanadium ELI alloy forgings for surgical implants"
- ASTM F648-00, "Standard specifications for ultra-high molecular weight polyethylene powder and fabricated form for surgical implants"
Labeling: As required by the risk analysis, the caution statement, intended use, and precautions recommended in the guidance document are provided in the labeling, package insert and surgical technique for the FMP Constrained Liner.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sterility Assurance Level (SAL): 10-6
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
0
APR 0 1 2003
510(k) Summary of Safety and Effectiveness
| 1) Submitter's name: | |
|---|---|
| Submitter's address: | |
| Submitter's telephone number: | |
| Contact person: | |
| Date summary prepared: |
Encore Orthopedics, Inc. 9800 Metric Blvd. Austin, TX 78758 (512) 834-6255 Debbie De Los Santos November 12, 2002
023794/
page 1 of 2
Trade or proprietary device name: (2) Common or usual name: Classification name:
FMP Constrained Liner Constrained Liner Class II (Special Controls)
Guidance Document: (3)
"Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented Prosthesis; Guidance for Industry and FDA"
(4) Subject device description:
The constrained liner is first snapped into the shell and a ridge or lip around the outside of the liner engages a groove on the inside of the shell to provide a positive lock. The femoral head is inserted into the constrained liner and the locking ring secures the head into the liner.
The Constrained Liner consists of an UHMWPE insert conforming to ASTM F648 and a titanium alloy locking ring conforming to ASTM F620. The ID of the liners is 28 mm and the minimum thickness of the insert is 6 mm. The constrained liner is to be used in conjunction with the acetabular shells previously cleared in K973199, K974093, and K974095.
Subject device intended use: 5)
The FMP Constrained Liner is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Risk Analvsis: (6)
| Identified Risk | Mitigation Measures | Acceptance Criteria | Results of Mitigation | Acceptance
Criteria Met |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------|
| Infection | Implants sold as sterile devices | Must provide a SAL of 10-6 | See Sterility below. | YES |
| Adverse Tissue
Reaction | Establish material and performance characteristics | Must meet the following standards:
ASTM F136-98
ASTM F620-00
ASTM F648-00 | See Standards Conformity below. | YES |
| Pain and/or
loss of
function | Establish material and performance characteristics | Must meet the following standards:
ASTM F136-98
ASTM F620-00
ASTM F648-00 | See Standards Conformity below. | YES |
| Revision | Include precautions and intended use on labeling and package inserts. Establish material and performance characteristics | Must include the precautions and intended use provided in the guidance document. Must meet the following standards:
ASTM F136-98
ASTM F620-00 | See Labeling below and Intended Use above. See Standards Conformity below. | YES |
1
| Identified Risk | Mitigation Measures | Acceptance Criteria | Results of Mitigation | Acceptance
Criteria Met? |
|--------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------|
| | | ASTM F648-00 | | |
| | Include precautions and intended use on labeling and package inserts. | Must include the precautions and intended use provided in the guidance document. | See Labeling below and Intended Use above. | |
| Device disassembly | Femoral head lever-out testing | Must meet or exceed the lever-out forces for Encore bipolar acetabulum | Testing was performed to show lever out mode exceeds those of the bipolar. | YES |
Sterilitv
All components are supplied sterile in triple sealed containers maintaining double sterile barriers. A combination of pouches and/or trays is used to provide the operating room staff with easy handling of the components. One hundred per cent visual examination of the package seals is performed and recorded. Sterilization is accomplished using gamma radiation (minimum 25 kGy) and is verified by dose validation per ANSVAAMI/ ISO11137-94 and EN552 to achieve a sterility assurance level of 10-6. In addition, B. pumilus biological indicators (population 100) are utilized as a secondary verification. No testing is performed to determine if these parts are pyrogen free. Resterilization of components using autoclave steam cycle is prohibited.
Standards Conformity
As required by the risk analysis, performance characteristics for all materials used in manufacturing the components of the FMP Constrained Liner meet one of the following material standards:
ASTM F136-98. "Standard specification for wrought Titanium-6 Vanadium ELI alloy for surgical implant applications"
- ASTM F620-00, "Standards specification for Titanium-6 Vanadium ELI alloy forgings for surgical implants"
- ASTM F648-00, "Standard specifications for ultra-high molecular weight polyethylene powder and fabricated form for surgical implants"
Labeling
As required by the risk analysis, the caution statement, intended use, and precautions recommended in the guidance document are provided in the labeling, package insert and surgical technique for the FMP Constrained Liner.
Predicate Device
The FMP Constrained liner is similar or identical in regards to material, design, sizing, and indications to Biomet's RingLoc (K950202), Poly-Dial - Johnson & Johnson (P960054) and Trilogy - Zimmer (K021826).
02 3794
page 2 of 2
2
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 stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 1 2003
Ms. Debbie De Los Santos Supervisor, Regulatory/Clinical Services Encore Medical Corporation 9800 Metric Boulevard Austin, Texas 78758
Re: K023794
Trade Name: FMP Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: January 21, 2003 Received: January 22, 2003
Dear Ms. De Los Santos:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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.
3
Page 2 – Ms. Debbie De Los Santos
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark N. Milkeran
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K023 774
510(k) Number (if known): ___ K 02 37 94
Device Name: FMP Constrained Liner
Indications For Use:
FMP Constrained Liner
Indications For Use
The FMP Constrained Liner is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ OR Over-The-Counter Use
(per 21 CFR 801.109)
(Optional Format 1-2-96)_
(Division Sign-Off)
Division of (neral, Restorative
and Neurological Devices
510(k) Number __ K023799
SK22
AR
II