(78 days)
No
The document describes a mechanical implant (acetabular system) and its materials and design modifications. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is an acetabular system used in hip replacement surgeries to treat damaged hips, which is a therapeutic intervention.
No
Explanation: The device described is an acetabular system (hip implant) used for surgical repair, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components (Acetabular shells and liners made of titanium alloy and polyethylene) and describes modifications to the physical shells. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing damaged hip joints. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and design of acetabular shells and liners, which are components of a hip replacement system. These are physical implants, not reagents or instruments used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing information for diagnosis, monitoring, or screening.
Therefore, the REFLECTION 3 Acetabular System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The REFLECTION 3 Acetabular System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, osteonecrosis, avascular necrosis, post traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseased and anomalies, and congenital dysplasia; old remote osteomyelitis with and an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The R3 Acetabular System is for single use only. The R3 Acetabular System is intended for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
MBL
Device Description
The REFLECTION 3 Acetabular System consists of Acetabular shells and liners. The R3 shells are manufactured from titanium alloy. The design of the shells and liners are similar to the REFLECTION 3 Acetabular Shell, the 10MRad REFLECTION 3 Acetabular Liner cleared under K061253 and the DePuy Pinnacle Acetabular Shell cleared under K033273. The REFLECTION 3 liners are manufactured from cross-linked polyethylene. The proposed modifications will include:
- The addition of Asymmetric Porous Coating to the outside of the R3 Acetabular Shell
- The addition of the R3 MAX shell with Asymmetric Porous Coating to the outside of the shell
- The addition of the R3 MAX shell with Titanium Bead Porous Coating to the outside of the shell
The Acetabular shells feature two locking grooves that correspond to locking beads on the XLPE liners, as cleared in K061253. There are also 12 indentions in the face of the shell that mate with twelve tabs of the XLPE liner to prevent rotation. The R3 Acetabular Shells and the R3 MAX shells will be offered in sizes 40mm-68mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K061253, K920430, K932755, K990666, K9640094, K002747, K033273
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.
Not Found
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
§ 888.3358 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.
0
K070756 (pg 1 of 2)
JUN - 6 2007
510{K} Summarv Smith & Nephew REFLECTION 3 Acetabular System
| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6017 |
| CONTACT PERSON: | Nicholas B. Tabrizi |
| DATE SUMMARY PREPARED: | February 1, 2007 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew REFLECTION 3 |
| COMMON OR USUAL NAME: | Acetabular Hip Prosthesis |
| CLASSIFICATION NAME: | Hip joint metal/polymer/metal semi-constrained porous-coated |
| uncemented prosthesis, 21 CFR 888.3358 | |
| DEVICE CLASS: | Class II |
| PANEL CODE: | Orthopaedics/87/MBL |
A. INTENDED USE:
The REFLECTION 3 Acetabular System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, osteonecrosis, avascular necrosis, post traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseased and anomalies, and congenital dysplasia; old remote osteomyelitis with and an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The R3 Acetabular System is for single use only. The R3 Acetabular System is intended for cementless use.
B. DEVICE DESCRIPTION:
The REFLECTION 3 Acetabular System consists of Acetabular shells and liners. The R3 shells are manufactured from titanium alloy. The design of the shells and liners are similar to the REFLECTION 3 Acetabular Shell, the 10MRad REFLECTION 3 Acetabular Liner cleared under K061253 and the DePuy Pinnacle Acetabular Shell cleared under K033273. The REFLECTION 3 liners are manufactured from cross-linked polyethylene. The proposed modifications will include:
- · The addition of Asymmetric Porous Coating to the outside of the R3 Acetabular Shell
- · The addition of the R3 MAX shell with Asymmetric Porous Coating to the outside of the shell
- · The addition of the R3 MAX shell with Titanium Bead Porous Coating to the outside of the shell
The Acetabular shells feature two locking grooves that correspond to locking beads on the XLPE liners, as cleared in K061253. There are also 12 indentions in the face of the shell that mate with
1
Kc70756 (pg 2 of 2)
twelve tabs of the XLPE liner to prevent rotation. The R3 Acetabular Shells and the R3 MAX shells will be offered in sizes 40mm-68mm.
SUBSTANTIAL EQUIVALENCE INFORMATION: ட்
The Smith & Nephew REFLECTION 3 is similar to the following commercially available devices regarding design features, overall indications, and materials:
- Smith & Nephew REFLECTION Acetabular System (K920430, K932755, K990666)
- = Smith & Nephew REFLECTION Interfit Shell (K9640094, K990666)
- = Smith & Nephew 10MRad REFLECTION Acetabular Liner (K002747)
- = Smith & Nephew REFLECTION 3 Acetabular System (K061253)
- DePuy Orthopaedics Inc. Pinnacle Acetabular System (K033273)
D. Summary of Technological comparison:
The intended use, design, and materials of the REFLECTION 3 Acetabular System are substantially equivalent to the previously cleared REFLECTION 3 Acetabular System (K061253). Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. Orthopaedic Division c/o Nicholas B. Tabrizi Regulatory Affairs Specialist II 1450 East Brooks Road Memphis, Tennessee 38116
JUN - 6 2007
Re: K070756
Trade/Device Name: Smith & Nephew REFLECTION 3 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: MBL
Dated: May 9, 2007 Received: May 10, 2007
Dear Mr. Tabrizi:
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 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 - Mr. Nicholas B. Tabrizi
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 on the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Raubare buerhus
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K070756
Device Name: Smith & Nephew REFLECTION 3 Acetabular System
Indications for Use:
A. Intended Use
The Smith & Nephew REFLECTION 3 is indicated for the following:
- Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, . avascular necrosis and post traumatic arthritis;
- Rheumatoid arthritis; .
- Slipped capital epiphysis; .
- Fused hip; .
- Fracture of the pelvis and diastrophic variant; �
- Old, remote osteomyelitis with an extended drainage-free period; �
- Revision procedures where other treatments have failed; and
- Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques:
- Femoral osteotomy; .
- Girdlestone resection; .
- Fracture dislocation of the hip and; ●
- Correction of deformity .
The REFLECTION 3 Acetabular System is for single use only. The REFLECTION 3 Acetabular System is intended for cementless use.
Over-The-Counter Use Prescription Use x AND/OR (Part 21 CFR 801 Subpart D) (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)
Debare Buehup
(Division Sign Off - date)
and Neurological
510(k) N
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