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Musculoskeletal Transplant Foundation

US

Last updated May 23, 2026

What Musculoskeletal Transplant Foundation makes

The Musculoskeletal Transplant Foundation produces human-derived bone matrix implants, including demineralized bone matrix (DBM) products like DBX®, and tendon grafts for orthopedic applications. It also supplies single-use general-purpose syringes for clinical use in surgical procedures.

These products are regulated under FDA Class I and Class II classifications, with authorizations recorded via 510(k) submissions and the FDA’s Unique Device Identifier (UDI) system. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
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LinkedIn
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EUDAMED SRN
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FDA FEI Number
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Catalogue (72)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
Dbx Demineralized Bone Matrix Putty K103795
FDA 510(k)
Class IIActive
Dbx Demineralized Bone Matrix Putty/Paste/Mix K053218
FDA 510(k)
Class IIActive
Mtf Allograft Anchor K042038
FDA 510(k)
Class IIActive
Allofix Anchor K053339
FDA 510(k)
Class IIActive
Dbx Demineralized Bone Matrix Putty K091218
FDA 510(k)
Class IIActive
Mtf Fascia K120479
FDA 510(k)
Class IIActive
Dbx Strip K062205
FDA 510(k)
Class IIActive
Mtf New Bone Void Filler K121313
FDA 510(k)
Class IIActive
Allofix Push-In Anchor K070347
FDA 510(k)
Class IIActive
Dbx Demineralized Bone Matrix Putty, Bone Matrix Paste And Bone Matrix Mix K040262
FDA 510(k)
Class IIActive
Sygnal Dbm K080405
FDA 510(k)
Class IIActive
Dbx Demineralized Bone Matrix Putty, Dbx Demineralized Bone Matrix Paste K080399
FDA 510(k)
Class IIActive
Dbx Demineralized Bone Matrix Putty K091217
FDA 510(k)
Class IIActive
Aft Allograft Filler Tube K060161
FDA 510(k)
Class IIActive
Mtf New Bone Voild Filler K113167
FDA 510(k)
Class IIActive
Dbx Demineralized Bone Matrix Mix K063676
FDA 510(k)
Class IIActive
MTF Pre-Sutured Tendon K181633
FDA 510(k)
Class IIActive
Sygnal Dbm K073329
FDA 510(k)
Class IIActive
Dbx Demineralized Bone Matrix Putty, Paste And Mix K040501
FDA 510(k)
Class IIActive
Mtf New Bone Void Filler K110003
FDA 510(k)
Class IIActive
Dbx Strip K042829
FDA 510(k)
Class IIActive
Allofix Anchor, 5.0 Mm Anchor K061498
FDA 510(k)
Class IIActive

Related Companies

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

The Musculoskeletal Transplant Foundation has nine recall records listed in the FDA database, initiated between December 4, 2014, and December 22, 2023. The recalls include open, classified, and terminated statuses, with reasons involving process qualification failures, labeling discrepancies (such as incorrect fill volumes, drill diameters, or measurement specifications), and packaging issues (e.g., unsealed pouches or improper seals). Some recalls cite potential impacts on surgical procedures, including extended surgery time or delays due to product inconsistencies.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Dec 22, 2023Z-1066-2024—open, classified

Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

Dec 22, 2023Z-1067-2024—open, classified

Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.

Sep 22, 2023Z-0323-2024—open, classified

Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.

Mar 29, 2021Z-1562-2021—terminated

3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery

Aug 15, 2019Z-2548-2019—terminated

Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.

Apr 21, 2016Z-2004-2016—terminated

AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field.

May 27, 2015Z-2210-2015—terminated

Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.

May 27, 2015Z-2075-2015—terminated

Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.

Dec 4, 2014Z-1455-2015—terminated

The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.