(184 days)
Indications for use with the CONSENSUS® Hip System or UNISYN™ Hip System:
A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
C) Proximal femoral fractures.
D) Avascular necrosis of the femoral head.
E) Non-union of proximal femoral neck fractures.
F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities
Acetabular components are indicated for cemented and cementless use.
Consensus femoral stems are indicated for cemented and cementless use.
UniSyn femoral stems are indicated for cementless use only.
HA coated implants are indicated for cementless use only.
The Consensus® Hip System (CHS) currently offers a semi-constrained metal-backed acetabular component comprising a porous coated shell manufactured from Titanium alloy (ASTM F620 or F136) (K922561, K020153, K060635) and a mating insert manufactured from ultra-high molecular weight polyethylene (UHMWPE) (K922561) (ASTM F648) or highly crosslinked UHMWPE (ASTM F648) (K021466, K070061). The shell is designed for uncemented press-fit or cemented use to the prepared acetabulum, and is designed to mate with the insert via secure insert/shell locking mechanism. The previously cleared inserts are designed to articulate with the CHS femoral heads.
The CS2™ Plus acetabular insert adds a lateralized configuration to the current line of CHS crosslinked UHMWPE acetabular inserts (i.e. CS2™ inserts) (K021466, K070061). The design intent is to allow the surgeon more intraoperative flexibility to medialize the acetabular cup or lateralize the head center, while maintaining substantial insert wall thickness.
This document describes the 510(k) summary for the Consensus Orthopedics, Inc. CS2™ Plus Acetabular Insert (K100933). It is not a study proving device performance against acceptance criteria in the manner typically seen for software or diagnostic devices. Instead, it is a submission demonstrating substantial equivalence to predicate devices for a medical implant.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, sample size for training set, ground truth for training set) are not applicable or cannot be extracted from this type of document.
However, I can extract information related to non-clinical testing performed to support the substantial equivalence claim, which serves as the "study" for this device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets in the same way a diagnostic algorithm's performance metrics would have. Instead, the "acceptance criteria" are implied by demonstrating that the CS2™ Plus Acetabular Insert performs comparably or better than the predicate CS2™ insert in specific mechanical tests, and that it is substantially equivalent in design and materials. The "reported device performance" are the results of these comparative tests.
| Test Performed | Implied Acceptance Criteria (Demonstrated Equivalence/Performance of Predicate) | Reported Device Performance (CS2™ Plus vs. CS2™) |
|---|---|---|
| Torsion testing of insert/shell locking mechanism | Acceptable locking mechanism integrity as demonstrated by predicate devices. | Testing performed for both CS2™ Plus and CS2™; results verified the new device is substantially equivalent to the predicate device. |
| Lever out testing | Acceptable resistance to dislodgement from the shell as demonstrated by predicate devices. | Testing performed for both CS2™ Plus and CS2™; results verified the new device is substantially equivalent to the predicate device. |
| Range of motion study | Acceptable range of motion for hip articulation, comparable to predicate devices. | Testing performed for both CS2™ Plus and CS2™; results verified the new device is substantially equivalent to the predicate device. |
| CAD verification study of locking mechanism | Geometrical compatibility and proper function of the locking mechanism. | Performed for both CS2™ Plus and CS2™; results verified the new device is substantially equivalent to the predicate device. |
| Push out testing | Acceptable resistance to insert push-out. | Performed for CS2™ (predicate); results implicitly used as a benchmark for the CS2™ Plus's substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
This is a materials and mechanical testing submission, not a data-driven algorithm submission. Therefore:
- Sample Size for the Test Set: Not specified in terms of clinical or image data. The "test set" would refer to the number of physical devices or components subjected to mechanical testing. This number is not disclosed in the summary, but typically would involve a standard number of samples per test type for statistical validity in engineering.
- Data Provenance: Not applicable in the sense of country of origin for clinical data. The tests are non-clinical (laboratory/mechanical).
- Retrospective or Prospective: Not applicable. These are laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context refers to engineering specifications and performance benchmarks, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. This document describes mechanical testing, not a clinical trial requiring adjudication of patient outcomes or expert reviews.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical implant, not an AI/imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm. The non-clinical testing performed is effectively "standalone" in that it tests the device's mechanical properties directly.
7. The Type of Ground Truth Used
The "ground truth" for this submission are established engineering standards for medical devices, the performance characteristics of the predicate devices, and the design specifications of the device itself (e.g., ensuring wall thickness, range of motion, locking mechanism integrity). It's based on mechanical testing results and CAD verification against design specifications and predicate device performance.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" in the context of an algorithm.
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KI009333
9. 510(K) SUMMARY
DCT & 2010
| Sponsor Name: | Consensus Orthopedics, Inc.1115 Windfield Way, Suite 100El Dorado Hills, CA 95762 |
|---|---|
| 510(k) Contact: | Matthew M. Hull, RACPhone: (916) 355-7156Fax: (916) 355-7190mhull@consensusortho.com |
| Date Prepared: | 1 October 2010 |
| Trade Name: | CS2™ Plus Acetabular Insert |
| Common Name: | Cross Linked Polyethylene, Lateralized, Acetabular Insert |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis (21 CFR 888.3358, Product Code LPH) |
| Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (21 CFR 888.3353, Product CodeLZO) | |
| Regulatory Class: | Class II |
Device Classification Panel: Orthopedic Devices
Predicate Device Identification:
The intended use, materials, and design features of the subject CS27M Plus acetabular insert are substantially equivalent to those of predicate devices manufactured by Consensus Orthopedics and competitors (Table 9.1). The safety and effectiveness of the CS2™ Plus insert are adequately supported by the substantial equivalence information and materials data provided within this Special 510(k) submission.
| 510(k)Number | Trade Name | 510(k) holder | 510(k) ClearanceDate |
|---|---|---|---|
| K922561 | Consensus™ Total Hip System | Consensus Orthopedics, Inc. | 07/21/1993 |
| K990135 | Trilogy Acetabular System LongevityCrosslinked Polyethylene | Zimmer, Inc. | 07/12/1999 |
| K994415 | Marathon Cross-linked PolyethyleneAcetabular Cup Liners | DePuy Orthopaedics, Inc. | 02/03/2000 |
| K001534 | Pinnacle Acetabular Cup System | DePuy Orthopaedics, Inc. | 06/12/2000 |
Table 9.1: Predicate device summary table.
Page 1 of 4
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| K010171 | Duraloc Acetabular Cup System, 36mmMarathon +4 Polyethylene Liner | DePuy Orthopaedics, Inc. | 04/06/2001 |
|---|---|---|---|
| K021466 | Consensus Acetabular Insert, Cross-Linked Polyethylene (CS2TM) | Consensus Orthopedics, Inc. | 07/24/2002 |
| K061253 | Reflection 3 Acetabular System | Smith & Nephew | 05/31/2006 |
| K070061 | 36mm CoCr Femoral Head and 36mmAcetabular Insert (CS2™) | Consensus Orthopedics, Inc. | 01/31/2007 |
Indications for use with the CONSENS® Hip System or UNISYN™ Hip System:
- A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
- F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities
Acetabular components are indicated for cemented and cementless use.
Consensus femoral stems are indicated for cemented and cementless use.
UniSyn femoral stems are indicated for cementless use only.
HA coated implants are indicated for cementless use only.
Device Description:
The Consensus® Hip System (CHS) currently offers a semi-constrained metal-backed acetabular component comprising a porous coated shell manufactured from Titanium alloy (ASTM F620 or F136) (K922561, K020153, K060635) and a mating insert manufactured from ultra-high molecular weight polyethylene (UHMWPE) (K922561) (ASTM F648) or highly crosslinked UHMWPE (ASTM F648) (K021466, K070061). The shell is designed for uncemented press-fit or cemented use to the prepared acetabulum, and is designed to mate with the insert via secure insert/shell locking mechanism. The previously cleared inserts are designed to articulate with the CHS femoral heads.
The CS2™ Plus acetabular insert adds a lateralized configuration to the current line of CHS crosslinked UHMWPE acetabular inserts (i.e. CS2™ inserts) (K021466, K070061). The design intent is to allow the surgeon more intraoperative flexibility to medialize the acetabular cup or lateralize the head center, while maintaining substantial insert wall thickness.
Comparison of Technological Characteristics:
The following features are common for the CS2™ Plus insert and the previously cleared CS2™ insert:
Page 2 of 4
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K100933
- Manufactured from DePuy Marathon® crosslinked UHMWPE (ASTM F648, (K994415). .
- Compatible with previously cleared CHS acetabular shells (K922561, K020153, . K060635), CHS femoral stems (K922561, K933499, K935453, K935193), CHS femoral heads (K953792, K960156, K030151, K070061), and UniSyn™ Hip System components (K003649, K062383) of the appropriate size.
- Identical articular surfaces designed to mate with 28mm, 32mm, and 36mm diameter . femoral heads.
- 28mm ID inserts accommodate the same number of shell sizes. .
- . Neutral and hooded configurations.
- o Hooded configurations feature an identical Titanium X-ray marker (ASTM F136).
- 0 28mm and 32mm inserts offer neutral or 20° hooded configurations.
- Minimum wall thickness at dome apex greater than 5mm. ●
- Identical insert/shell locking mechanism. .
- Identical minimum intended range of motion. .
The following features are unique to the CS2™ Plus insert in comparison to the previously cleared CS2TM insert:
- The CS2™ Plus insert is designed to position the femoral head center 5mm more laterally . than that of the CS2TM insert.
- 32mm CS2™ Plus insert will accommodate two additional shell sizes (48 and 50mm . OD), which are currently only compatible with 28mm CS2™ inserts.
- 36mm CS2™ Plus insert will accommodate two additional shell sizes (52 and 54mm . OD), which are currently only compatible with 28mm and 32mm CS2TM inserts.
- Will not accommodate 22mm heads. .
- 36mm CS2™ Plus inserts offer neutral or 10° hooded configurations, whereas the 36mm . CS2™ inserts offer neutral, 10°, or 20° hooded configurations.
- The CS2™ Plus insert will have an increased wall thickness at the apex of the dome and . beneath the external snap feature due to the 5mm lateral offset.
- When mated with the acetabular shell, the CS2™ Plus insert will extend further outside . the shell by 5mm due to the 5mm lateral offset of the head center.
Summary of Nonclinical Testing and Evaluation:
The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA). The risk analysis was performed according to the requirements of ISO 14971:2007 "Medical Devices – Application of risk management to medical devices". Records of the risk analysis process are retained in the design history file.
Based upon the fact that the new CS2 Plus Acetabular Inserts represent a line extension of the current CS2 inserts the following preclinical testing/evaluation was preformed:
-
- Torsion testing of insert/shell locking mechanism (CS2 Plus & CS2)
-
- Lever out testing (CS2 Plus & CS2)
-
- Range of motion study (CS2 Plus & CS2)
Page 3 of 4
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K 100933
-
- CAD verification study of locking mechanism (CS2 Plus & CS2)
-
- Push out testing (CS2)
The results of the above testing verify that the new device is substantially equivalent to the predicate device.
Page 4 of 4
・。
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 a stylized image of an eagle or other bird with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Consensus Orthopedics, Inc. % Mr. Matthew M. Hull, RAC Director QS & RA 1115 Windfield Way Suite 100 El Dorado Hills, California 95762
OCT 6 2010
Re: K100933
Trade/Device Name: CONSENSUS® Hip System: CS2™ Plus Acetabular Insert 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: September 10, 2010 Received: September 15, 2010
Dear Mr. Hull:
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. Iisting 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
. I
.. ' ...
{5}------------------------------------------------
Page 2 - Mr. Matthew M. Hull, RAC
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
cerely yours,
for Nollm Din
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K100933
Device Name: CONSENSUS® Hip System: CS2TM Plus Acetabular Insert
Indications for use with the CONSENSUS® Hip System or UNISYN™ Hip System
- A ) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
- F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities
Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.
Prescription Use_ X (21 CFR. Part 801 Subpart D) AND/OR
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soutu for nxm
(Division Sign-Off)
Division of Surgical, Grinopedic, and Restorative Devices
510(k) Number K100933
§ 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.