K Number
K181732
Device Name
InterSpace Knee Extra-Large Size, InterSpace Knee ATS
Manufacturer
Date Cleared
2019-04-27

(299 days)

Product Code
Regulation Number
888.3560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterSpace Knee is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), the is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present. InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee ATS is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
Device Description
The InterSpace Knee, cleared by FDA via K101356 and K062274, is a temporary spacer device available in three sizes (S-M-L). With this 510(k) submission, Tecres is adding the additional XL size to the FDA cleared range of InterSpace Knee sizes. The InterSpace Knee ATS is a temporary spacer device available in four sizes, intended to be combined with the tibial component of InterSpace Knee. Specific sizes of the InterSpace Knee ATS are compatible with certain InterSpace Knee sizes. The devices, as single device (InterSpace Knee, K101356 and K062274) or once InterSpace Knee is combined with the InterSpace Knee ATS, provide patients with a temporary, complete knee implant that allows for a natural range of motion and partial weight-bearing during treatment of the infection, and preserves the soft tissue to prevent further complications, such as muscular contraction, to facilitate the subsequent joint replacement procedure after systemic treatment of the underlying infection. The InterSpace Knee XL size and InterSpace Knee ATS components are sterile, single-use device intended for temporary use (maximum 180 days) as a partial joint replacement. The devices are made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains gentamicin. The mass used to fill the molds (the unformed PMMA resin) is prepared from powder and liquid components. The liquid component consists of methylmethacrylate (MMA), N,N- dimethyl-p-toluidine and hydroquinone; the powder component consists of PMMA, barium sulphate, benzoyl peroxide and gentamicin sulphate.
More Information

No
The summary describes a physical implantable device made of PMMA and gentamicin, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Yes.
The device acts as a temporary total knee replacement and delivers gentamicin for the treatment of a septic process.

No

The device is a temporary knee replacement/spacer used during a two-stage procedure for septic processes, not for diagnosing conditions.

No

The device description explicitly states it is a physical, temporary spacer device made of polymethylmethacrylate (PMMA) and contains gentamicin, intended for surgical implantation. It is not software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description and Intended Use: The InterSpace Knee and InterSpace Knee ATS are described as temporary spacer devices intended for surgical implantation in the knee joint during a two-stage procedure for septic processes. They are physical implants made of PMMA and gentamicin, designed to provide mechanical support and deliver antibiotics locally.
  • Lack of Diagnostic Function: The device does not perform any tests on biological samples to diagnose or monitor a condition. Its function is entirely mechanical and therapeutic (local antibiotic delivery).

Therefore, the InterSpace Knee and InterSpace Knee ATS fall under the category of medical devices (specifically, orthopedic implants), but not in vitro diagnostic devices.

N/A

Intended Use / Indications for Use

InterSpace Knee

InterSpace Knee is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), the is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

InterSpace Knee ATS

InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present.

InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

InterSpace Knee ATS is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Product codes

JWH

Device Description

The InterSpace Knee, cleared by FDA via K101356 and K062274, is a temporary spacer device available in three sizes (S-M-L). With this 510(k) submission, Tecres is adding the additional XL size to the FDA cleared range of InterSpace Knee sizes.

The InterSpace Knee ATS is a temporary spacer device available in four sizes, intended to be combined with the tibial component of InterSpace Knee. Specific sizes of the InterSpace Knee ATS are compatible with certain InterSpace Knee sizes.

The devices, as single device (InterSpace Knee, K101356 and K062274) or once InterSpace Knee is combined with the InterSpace Knee ATS, provide patients with a temporary, complete knee implant that allows for a natural range of motion and partial weight-bearing during treatment of the infection, and preserves the soft tissue to prevent further complications, such as muscular contraction, to facilitate the subsequent joint replacement procedure after systemic treatment of the underlying infection.

The InterSpace Knee XL size and InterSpace Knee ATS components are sterile, single-use device intended for temporary use (maximum 180 days) as a partial joint replacement. The devices are made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains gentamicin. The mass used to fill the molds (the unformed PMMA resin) is prepared from powder and liquid components. The liquid component consists of methylmethacrylate (MMA), N,N- dimethyl-p-toluidine and hydroquinone; the powder component consists of PMMA, barium sulphate, benzoyl peroxide and gentamicin sulphate.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee

Indicated Patient Age Range

Skeletally mature patients

Intended User / Care Setting

Orthopedic surgeons for two-stage knee revision procedure

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)

Performance evaluation to establish the substantial equivalence of the InterSpace Knee (XL size) to the other sizes already FDA cleared (K06274 and K101356).

  • Static performances of the resin (ISO 5833): Resin was tested and shown to meet the minimum requirements of ISO 5833.
  • Fatigue performances of the resin (ASTM F2118): Resin was tested and shown to meet the acceptance criteria according to ASTM F2118.
  • Fatigue test: the bigger size (XL) has been demonstrated to be a better case compared to the other InterSpace Knee sizes (S-M-L).
  • Wear test: an evaluation of the debris has been compared with another temporary spacer already cleared by FDA.
  • Surface Roughness: surface roughness is the same of the other sizes already approved.
  • Antibiotic (gentamicin) elution testing: The gentamicin elution profile demonstrated substantial equivalence with gentamicin elution of another temporary spacer already cleared by FDA.
    The performance data demonstrate that the new device is substantially equivalent to the predicate device.

Performance data to establish the substantial equivalence of the InterSpace Knee ATS to the predicate device or the reference device.

  • Static performances of the resin (ISO 5833): Resin was tested and shown to meet the minimum requirements of ISO 5833.
  • Fatigue performances of the resin (ASTM F2118): Resin was tested and shown to meet the acceptance criteria according to ASTM F2118.
  • Fatigue test on the device has been performed according to ASTM F1800.
  • Antibiotic (gentamicin) elution testing: The gentamicin elution profile demonstrated substantial equivalence with gentamicin elution of another temporary spacer already cleared by FDA.
    The performance data demonstrate that the new device is substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K062274, K101356, K112470

Reference Device(s)

K062274, K101356

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.

0

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Tecres S.p.A. % Christine Brauer, Ph.D. Regulatory Affairs Consultant Brauer Device Consultants, LLC 7 Trail House Court Rockville, Maryland 20850

Re: K181732

Trade/Device Name: InterSpace Knee Extra-Large Size, InterSpace Knee ATS Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 27, 2019 Received: March 28, 2019

Dear Dr. Brauer:

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.

1

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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, fi 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K181732

Device Name InterSpace Knee Extra-Large Size InterSpace Knee ATS

Indications for Use (Describe)

InterSpace Knee is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), the is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period

InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present.

InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

InterSpace Knee ATS is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

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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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant Information

| Applicant: | Tecres S.p.A.
Via A. Doria 6
37066 Sommacampagna
Verona - Italy |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Christine Brauer
US Agent for Tecres, S.p.A.
Brauer Device Consultants, LLC
7 Trail House Court
Rockville, MD 20850
Telephone: 301 545-1990
Email: chris.brauer@comcast.net |
| Date of Preparation: | March 27, 2019 |
| 510(k) Number: | K181732 |

Device Information

| Trade/Proprietary Name: | InterSpace Knee (XL size)
InterSpace Knee ATS |
|----------------------------|---------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Temporary Knee Spacer with Gentamicin
Temporary Augmented Tibial Stem Spacer with gentamicin |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis |
| Classification Regulation: | 21 CFR 888.3560 |
| Class: | II |
| Product Code: | JWH - Prosthesis, knee, patellofemorotibial, semi-constrained,
cemented, polymer/metal/polymer |
| Panel: | Orthopedic |

4

Device Description

The InterSpace Knee, cleared by FDA via K101356 and K062274, is a temporary spacer device available in three sizes (S-M-L). With this 510(k) submission, Tecres is adding the additional XL size to the FDA cleared range of InterSpace Knee sizes.

The InterSpace Knee ATS is a temporary spacer device available in four sizes, intended to be combined with the tibial component of InterSpace Knee. Specific sizes of the InterSpace Knee ATS are compatible with certain InterSpace Knee sizes.

The devices, as single device (InterSpace Knee, K101356 and K062274) or once InterSpace Knee is combined with the InterSpace Knee ATS, provide patients with a temporary, complete knee implant that allows for a natural range of motion and partial weight-bearing during treatment of the infection, and preserves the soft tissue to prevent further complications, such as muscular contraction, to facilitate the subsequent joint replacement procedure after systemic treatment of the underlying infection.

The InterSpace Knee XL size and InterSpace Knee ATS components are sterile, single-use device intended for temporary use (maximum 180 days) as a partial joint replacement. The devices are made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains gentamicin. The mass used to fill the molds (the unformed PMMA resin) is prepared from powder and liquid components. The liquid component consists of methylmethacrylate (MMA), N,N- dimethyl-p-toluidine and hydroquinone; the powder component consists of PMMA, barium sulphate, benzoyl peroxide and gentamicin sulphate.

Indication for Use

InterSpace Knee

InterSpace Knee is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Interspace Knee is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

5

InterSpace Knee ATS

InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present.

InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

InterSpace Knee ATS is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/ polymethylmethacrvlate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

InterSpace Knee (XL size): Substantial Equivalence Comparison

For purposes of the substantial equivalence comparisons, the following predicate device was selected:

  • Tecres S.p.A. InterSpace Knee which was cleared through 510(k) applications . K062274 and K101356.
    Intended Use: The InterSpace Knee is intended to be used for patients undergoing a two-stage revision procedure for an infection of a total knee implant. The intended use of the XL size is exactly the same as for the other FDA cleared sizes (S-M-L) (see Table 1).

| Characteristic | InterSpace Knee (XL size) - Subject
Device | InterSpace Knee - Predicate Device
(K101356, K062274) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Regulation | 888.3560 | 888.3560 |
| Product Code | JWH | JWH |
| Class | II | II |
| Indication for Use | ...is indicated for temporary use
(maximum 180 days) as a total knee
replacement (TKR) in skeletally
mature patients undergoing a two-
stage procedure due to a septic
process... | ...is indicated for temporary use
(maximum 180 days) as a total knee
replacement (TKR) in skeletally mature
patients undergoing a two-stage
procedure due to a septic process... |
| Primary Function | Provide a temporary implant to allow
for natural range of motion and partial
weight-bearing | Provide a temporary implant to allow for
natural range of motion and partial
weight-bearing |
| Secondary Function | Preserve soft tissue structure
To release antibiotics (gentamicin) in
the local area | Preserve soft tissue structure
To release antibiotics (gentamicin) in the
local area |

Table 1. Summary of Intended Use for the InterSpace Knee XL Size Compared to the Predicate Device

6

| Characteristic | InterSpace Knee (XL size) - Subject
Device | InterSpace Knee - Predicate Device
(K101356, K062274) |
|--------------------------------|----------------------------------------------------|----------------------------------------------------------|
| Target Patient
Population | Patients with an infected total knee
prosthesis | Patients with an infected total knee
prosthesis |
| | Intended Users | Orthopedic surgeons |
| Intended Surgical
Procedure | Two-stage knee revision procedure | Two-stage knee revision procedure |
| | Body Contact and
Duration | Bone – Maximum of 180 days |
| Prescription Device | | Yes |

Comparison of the Technological Characteristics: All the InterSpace Knee sizes (S-M-L-XL) share the same design and technological characteristics (see Table 2).

| Characteristic | Tecres S.p.A. -
InterSpace Knee (XL size) -
Subject Device | Tecres S.p.A. -
InterSpace Knee - Predicate
Device (K101356, K062274) |
|---------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Main Components | Polymethylmethacrylate
(PMMA)
Methylmethacrylate (MMA)
Barium Sulphate | Polymethylmethacrylate (PMMA)
Methylmethacrylate (MMA)
Barium Sulphate |
| Other Components | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone |
| Antibiotic | Gentamicin Sulphate | Gentamicin Sulphate |
| Design (shape) | Femoral + Tibial | Femoral + Tibial |
| Sizes | 1 size of femoral + tibial
component (XL) | 3 sizes of femoral + tibial
component (S, M, L) |
| X-ray visibility | Yes | Yes |
| Single-use device | Yes | Yes |
| Provided Sterile | Yes | Yes |
| Spacer Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Sterility Assurance Level (SAL)
– Powder | 10-6 | 10-6 |
| Shelf Life | 5 years | 5 years |

Table 2: Summary of Technological Characteristics between the InterSpace Knee (XL size) and InterSpace Knee Other Sizes (S-M-L)

Performance Data: This 510(k) notification provided performance evaluation to establish the substantial equivalence of the InterSpace Knee (XL size) to the other sizes already FDA cleared (K06274 and K101356).

Sterilization and Shelf Life: The devices are sterilized using standard methods and the sterilization cycles have been validated following international standards. The sterilization validation complies with: UNI EN ISO 11135:2014; EC 1-2011 UNI EN ISO 11737-1:2006, UNI EN ISO 11737-2:2010, UNI EN ISO 10993-7:2009, UNI EN 556-1:2002, EP current

7

Edition. The sterilization cvcle was validated to a sterility assurance level of 10-6. The shelf life was established through real-time and accelerated aging studies. All demonstrate a shelf life of 5 years.

Biocompatibility: Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" have been taken into account to evaluate the biocompatibility of the device materials. All the Interspace Knee spacer devices (including the XL size) are manufactured with same materials using the same manufacturing process: they share the same tissue contact and duration of contact.

Performance Testing: Performance testing was performed to characterize the InterSpace Knee (XL size):

  • Static performances of the resin (ISO 5833): Resin was tested and shown to meet the ● minimum requirements of ISO 5833.
  • Fatigue performances of the resin (ASTM F2118): Resin was tested and shown to meet ● the acceptance criteria according to ASTM F2118.
  • . Fatigue test: the bigger size (XL) has been demonstrated to be a better case compared to the other InterSpace Knee sizes (S-M-L).
  • Wear test: an evaluation of the debris has been compared with another temporary spacer ● already cleared by FDA.
  • Surface Roughness: surface roughness is the same of the other sizes already approved
  • Antibiotic (gentamicin) elution testing: The gentamicin elution profile demonstrated . substantial equivalence with gentamicin elution of another temporary spacer already cleared by FDA.

The performance data demonstrate that the new device is substantially equivalent to the predicate device.

InterSpace Knee ATS: Substantial Equivalence Comparison

For purposes of the substantial equivalence comparisons, the following predicate device was selected:

  • Knee Modular Spacer which was submitted by Garventis, LLC and cleared through 510(k) application K112470.
    The InterSpace Knee ATS when combined with the InterSpace Knee provides a total temporary knee spacer for patients with a large tibial defect; this is analogous to the Knee Modular Spacer.

The following device was selected as a reference device:

  • . Tecres S.p.A. InterSpace Knee which was cleared originally through 510(k) applications K062274 and K101356.

8

Intended Use: The InterSpace Knee ATS is intended to be used with the InterSpace Knee for patients undergoing a two-stage revision procedure for an infection of a total knee implant who have a large tibial defect. This is the same intended use as the predicate Knee Modular Spacer (see table below). Both devices provide the same primary function; i.e., allowing for natural range of motion and partial weight bearing and preserving the soft tissue structure. Thus, the InterSpace Knee ATS has the same intended use as the predicate device.

| Characteristics | InterSpace Knee ATS Plus
InterSpace Knee | Knee Modular Spacer - Predicate
Device |
|--------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Classification Regulation | 888.3560 | 888.3360 |
| Product Code | JWH | JWH |
| Class | II | II |
| Primary Function | Provide a temporary implant to allow
for natural range of motion and partial
weight-bearing | Provide a temporary implant to allow
for natural range of motion and partial
weight-bearing |
| | Preserve soft tissue structure | Preserve soft tissue structure |
| Secondary Function | To release antibiotic (gentamicin) in
the local area | To release antibiotic (gentamicin) in
the local area |
| Target Patient Population | Patients with an infected knee
prosthesis | Patients with an infected knee
prosthesis |
| Intended Users | Orthopedic surgeons | Orthopedic surgeons |
| Intended Surgical
Procedure | Two-stage knee revision procedure | Two-stage knee revision procedure |
| Body Contact and
Duration | Bone – Maximum of 180 days | Bone – Maximum of 180 days |
| Prescription Device | Yes | Yes |

Table 3. Summary of Intended Use for the InterSpace Knee ATS plus InterSpace Knee Compared to the Predicate Device

Comparison of the Technological Characteristics: The combined InterSpace Knee ATS plus InterSpace Knee share the same design and technological characteristics as the Knee Modular Spacer (see table). Both temporary spacers are made from gentamicin-loaded PMMA bone cement. Both consist of modular components with a tibial insert. Both are provided sterile for single-use.

Table 4: Summary of Technological Characteristics between the InterSpace Knee ATS plus InterSpace
Knee and the Predicate Device
CharacteristicsInterSpace Knee ATS Plus InterSpace
KneeKnee Modular Spacer – Predicate
Device
Total Knee
ComponentsFemoral component
Tibial component
ATS component (optional)Femoral component
Tibial component
Tibial insert (optional)
Component
MaterialsAntibiotic loaded PMMAAntibiotic loaded PMMA with color
additive (details not specified in the 510k
Summary)
AntibioticGentamicinGentamicin
Sizes4 InterSpace Knee (femoral + tibial)
4 InterSpace Knee ATSFemoral and tibial components
Optional tibial insert

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CharacteristicsInterSpace Knee ATS Plus InterSpace KneeKnee Modular Spacer - Predicate Device
Available in a range of sizes; further details unspecified in 510(k) Summary
ModularityYes. InterSpace Knee ATS matches in size to be compatible with specific InterSpace Knee sizes.Yes. Femoral component can be combined with tibial component; tibial component can be combined with optional tibial insert
AugmentATS componentTibial insert
Function of the AugmentOptional
Increase the thicknessOptional
Increase the thickness
RadiopaqueYesYes
Single-use deviceYesYes
Provided SterileYesYes

For a comparison of certain technological characteristics, the InterSpace Knee ATS is compared to the InterSpace Knee as a reference device. The InterSpace Knee ATS shares many of the same technological characteristics as the InterSpace Knee, including the identical materials, and same PMMA bone cement formulation including antibiotic concentration. The technological characteristics are the same between the proposed device and the reference device (see table).

CharacteristicsInterSpace Knee ATSInterSpace Knee
Main ComponentsPolymethylmethacrylate (PMMA)
Methylmethacrylate (MMA)
Barium SulphatePolymethylmethacrylate (PMMA)
Methylmethacrylate (MMA)
Barium Sulphate
Other ComponentsBenzoyl peroxide
N,N-Dimethyl-p-toluidine
HydroquinoneBenzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone
AntibioticGentamicin SulphateGentamicin Sulphate
Design (shape)Tibial Augment for use with the
InterSpace KneeFemoral + Tibial
Sizes4 sizes matching the InterSpace Knee
tibial components4 sizes
X-ray visibilityYesYes
Single-use deviceYesYes
Provided SterileYesYes
Spacer Sterilization
MethodEthylene OxideEthylene Oxide
Sterility Assurance
Level (SAL) -
Powder10-610-6
Shelf Life5 years5 years

Table 5: Summary of Technological Characteristics between the InterSpace Knee ATS and the InterSpace Knee

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Performance Data: This 510(k) notification provided performance data to establish the substantial equivalence of the InterSpace Knee ATS to the predicate device or the reference device. The following is a summary of the performance data.

Sterilization and Shelf Life: The devices are sterilized using standard methods and the sterilization cycles have been validated following international standards. The sterilization validation complies with: UNI EN ISO 11135:2014; EC 1-2011 UNI EN ISO 11737-1:2006. UNI EN ISO 11737-2:2010, UNI EN ISO 10993-7:2009, UNI EN 556-1:2002, EP current Edition. The sterilization cycle was validated to a sterility assurance level of 106. The shelf life was established through real-time and accelerated aging studies. All demonstrate a shelf life of 5 years.

Biocompatibility evaluation has been performed to show the device Biocompatibility: materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" have been taken into account to evaluate the biocompatibility of the device materials. The device materials of the InterSpace Knee ATS are identical to the InterSpace Knee, which share the same tissue contact and duration of contact.

Performance Testing: Performance testing was performed to characterize the InterSpace Knee ATS. Performance testing was performed on either the InterSpace Knee ATS or the InterSpace Knee and included an evaluation of the following:

  • Static performances of the resin (ISO 5833): Resin was tested and shown to meet the ● minimum requirements of ISO 5833.
  • Fatigue performances of the resin (ASTM F2118): Resin was tested and shown to meet the acceptance criteria according to ASTM F2118.
  • Fatigue test on the device has been performed according to ASTM F1800. ●
  • Antibiotic (gentamicin) elution testing: The gentamicin elution profile demonstrated substantial equivalence with gentamicin elution of another temporary spacer already cleared by FDA.

The performance data demonstrate that the new device is substantially equivalent to the predicate device.