(102 days)
Not Found
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 total hip replacement system, which reconstructs damaged hip joints to alleviate pain and restore function in patients with severe joint diseases, directly providing a therapeutic effect.
No
The device description clearly states it is a "non-cemented primary hip prosthesis" including "femoral stem, femoral Head, acetabular poly liner, and acetabular metal (or shell) components," which are used for "cementless reconstruction of the articulating surface [...] of the hip." This indicates it is an implant, not a device used to diagnose a medical condition.
No
The device description clearly outlines physical implant components made of materials like Ti 6AL 4V, CoCr, BIOLOX® delta ceramic, and UHMWPE polyethylene. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implant for surgical reconstruction of the hip joint. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a physical implant system consisting of components like a femoral stem, head, and acetabular components. These are physical devices implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Precision Casting Solutions Total Hip System implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- · Rheumatoid arthritis or traumatic arthritis
- · Correction of functional deformity
- · Non-union femoral neck fracture
· Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
Product codes
LPH, LZO
Device Description
The present 510k submission is for a non-cemented primary hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral Head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The uni-polar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.
The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offerent inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components.
The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in nohole, cluster-hole, and revision multi-hole styles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral and/or acetabular portions of the hip
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
Extensive preclinical performance testing was conducted, and substantial equivalence determined per K143314 and K151424. The components of the subject device are identical to the predicate device, and therefore the predicate device testing demonstrates substantial equivalence for the subject device. The results confirm that all components of the Precision Casting Solutions Total Hip System exhibit the appropriate mechanical characteristics for total hip joint replacement and is substantially equivalent to the predicate devices.
- Fatigue Performance Test for Precision Casting Solutions Stem
- Fatigue Performance Test for the Neck Portion of the Precision Casting Solutions Stem
- Disassembly Force Test for Precision Casting Solutions Neck Taper/Femoral Head Interface
- Range of Motion Test for the Precision Casting Solutions Total Hip System
- Burst Strength Test for Precision Casting Solutions Ceramic Femoral Heads (Static Compression)
- Cyclic Fatigue Test for Precision Casting Solutions Ceramic Femoral Heads (Cyclic Compression)
- Post-Cvclic Fatigue Burst Test for Precision Casting Solutions Ceramic Femoral Heads (Static Compression)
- Pull-Off Test for Precision Casting Solutions Ceramic Femoral Heads
- Rotational Stability Test for Precision Casting Solutions Ceramic Femoral Heads
- Torsional Properties Test for Precision Casting Solutions Bone Screws
- Driving Torque Test for Precision Casting Solutions Bone Screws
- Axial Pull-Out Strength Test for Precision Casting Solutions Bone Screws
- Lever-Out Test for Precision Casting Solutions Acetabular Shell/Liner Assembly
- Torque-Out Test for Precision Casting Solutions Acetabular Shell/Liner Assembly
- Push-In Test for Precision Casting Solutions Acetabular Shell/Liner Assembly
- Push-Out Test for Acetabular Shell/Liner Precision Casting Solutions Assembly
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure, while the FDA acronym and full name are written in blue, with the acronym in a blue square.
December 17, 2019
Precision Casting Solution, LLC Jim Moore Vice President 200031 Henrici Road OREGON CITY OR 97045
Re: K192450
Trade/Device Name: Precision Casting Solutions Total Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, LZO Dated: August 30, 2019 Received: September 6, 2019
Dear Jim Moore:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K192450
Device Name Precision Casting Solutions Total Hip System
Indications for Use (Describe)
The Precision Casting Solutions Total Hip System implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- · Rheumatoid arthritis or traumatic arthritis
- · Correction of functional deformity
- · Non-union femoral neck fracture
· Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the letters "P", "C", and "S" in both blue and pink colors. There is a medical symbol in the background. In the foreground, there are two DNA strands, one in blue and the other in pink.
510(k) Summary 1.
The following 510(k) Summary is provided in accordance with 21 CFR 807.92.
510(k) Owner and Registration 1.1
| Owner's Name: | Precision Casting Solutions, INC |
|---|---|
| Address: | 20031 Henrici Road., Oregon City, OR 97045 |
| Phone Number: | (503) 421-1251 |
| Fax Number: | N/A |
| Date Summary Prepared: | August 30, 2019 |
| Establishment Registration | |
| Number: | N/A |
1.2 510(k) Contact
| Contact: | Jim Moore |
|---|---|
| Address: | 20031 Henrici Road |
| Oregon City, OR 97045 | |
| Phone Number: | (503) 421-1251 |
| Fax Number: | N/A |
| Contact Person: | Jim Moore |
1.3 Device Name and Classification
| Device Trade Name: | Precision Casting Solutions Total Hip System |
|---|---|
| Device Common Name: | Total Hip Replacement |
| Regulation Number and | |
| Description: | 21 CFR 888.3558 |
| Device Class: | Class II |
| Product Codes: | LPH, LZO |
| Advisory Panel: | 87 (Orthopedic) |
Legally Marketed Predicate 1.4
Precision Casting Solutions is utilizing the Progressive Orthopaedic Total Hip System as the predicate device (K143314/K151424). The Precision Casting Solutions Total Hip System features component designs, materials, indications, manufacturing methods, and contract manufacturer's that are identical to the Progressive Orthopaedic Total Hip System.
1.5 Device Description
The present 510k submission is for a non-cemented primary hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral Head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The uni-polar femoral
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Image /page/4/Picture/0 description: The image shows a logo with the letters "P", "C", and "S" on both the left and right sides. The letters on the left are in blue, while the letters on the right are in pink. In the background, there is a faint image of a caduceus, a symbol associated with medicine. Below the letters and the caduceus, there is a depiction of a DNA double helix, with one strand in blue and the other in pink.
head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.
The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offerent inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components.
The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in nohole, cluster-hole, and revision multi-hole styles.
1.6 Indications For Use
The Precision Casting Solutions Total Hip System is identical to the predicate Progressive Orthopaedic Total Hip System. The indications for use are also identical.
The Precision Casting Solutions Total Hip System implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis or traumatic arthritis .
- · Correction of functional deformity
- . Non-union femoral neck fracture
- Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other ● techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
1.7 Summary of Technological Characteristics
The Precision Casting Solutions Total Hip system is identical to the predicate Progressive Orthopaedic Total Hip System. Both devices are manufactured from identical materials, possess the same the same packaging and sterilization processes. Extensive precimical testing was performed on the predicate devices per K143314 and K151424 and found substantially equivalent. The performance tests are listed below and used herein to establish substantial equivalence (Section Error! Reference source not found. Error! Reference source not found.)
Given that the subject device is identical to the subject system is substantially equivalent to the predicate systems (K143314/K151424).
1.8 Performance Testing
Extensive preclinical performance testing was conducted, and substantial equivalence determined per K143314 and K151424. The components of the subject device are identical to the predicate device, and therefore the predicate device testing demonstrates substantial equivalence for the subject device. The results confirm that all components of the Precision Casting Solutions Total Hip System exhibit the appropriate mechanical characteristics for total hip joint replacement and is substantially equivalent to the predicate devices.
- Fatigue Performance Test for Precision Casting Solutions Stem .
- . Fatigue Performance Test for the Neck Portion of the Precision Casting Solutions Stem
- Disassembly Force Test for Precision Casting Solutions Neck Taper/Femoral Head Interface
- Range of Motion Test for the Precision Casting Solutions Total Hip System
- Burst Strength Test for Precision Casting Solutions Ceramic Femoral Heads (Static Compression)
- . Cyclic Fatigue Test for Precision Casting Solutions Ceramic Femoral Heads (Cyclic Compression)
- . Post-Cvclic Fatigue Burst Test for Precision Casting Solutions Ceramic Femoral Heads (Static Compression)
- . Pull-Off Test for Precision Casting Solutions Ceramic Femoral Heads
- Rotational Stability Test for Precision Casting Solutions Ceramic Femoral Heads
- Torsional Properties Test for Precision Casting Solutions Bone Screws
- Driving Torque Test for Precision Casting Solutions Bone Screws ●
- Axial Pull-Out Strength Test for Precision Casting Solutions Bone Screws .
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Image /page/5/Picture/0 description: The image shows a logo with the letters "P", "C", and "S" arranged in a specific pattern. On the left side, the letters "P", "C", and "S" are in blue, while on the right side, they are in pink. Below the letters, there is a depiction of a DNA double helix, with one strand in blue and the other in pink. In the background, there is a medical symbol, suggesting a connection to healthcare or medicine.
- Lever-Out Test for Precision Casting Solutions Acetabular Shell/Liner Assembly .
- Torque-Out Test for Precision Casting Solutions Acetabular Shell/Liner Assembly
- Push-In Test for Precision Casting Solutions Acetabular Shell/Liner Assembly ●
- Push-Out Test for Acetabular Shell/Liner Precision Casting Solutions Assembly ●
1.9 Conclusions
The Precision Casting Solutions Total Hip System is identical to the predicate Progressive Orthopaedic Total Hip System. The subject device has the same design features, materials, and indications for use as the predicate devices. The testing performed for the predicate device indicates that the Precision Casting Solutions Total Hip System is safe for clinical use.
The Precision Casting Solutions Total Hip System is substantially equivalent to the predicate device.