CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION— 510(k) K100986

Clearance details

Applicant

Skeletal Kinetics, LLC

Product code

Code MQV

Device class

Class 2

Regulation

21 CFR 888.3045

Advisory panel

Orthopedic

Date received

2010-04-09

Decision date

2010-07-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cupertino, CA, US

• K262230 — Mg OSTEOREVIVE; Mg OSTEOCRETE2026-09-11
• K260364 — Device 300419 Strip2026-06-02
• K252797 — JAZBI Resorbable Bone Void Filler2026-05-26
• K261008 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip +7 more2026-04-24
• K253524 — Adaptos®Fuse Bone Graft2026-02-17

• K162864 — OsteoVation Impact2017-01-13
• K132211 — SKAFFOLD NMX BONE VOID FILLER2014-08-04
• K120354 — BETA-TCP GRANULES2013-03-21
• K112383 — CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER2012-02-07
• K111538 — SKAFFOLD CIS2011-10-25

Death

6

Injury

435

Total

441

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2595-2020 — ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.Class II·Terminated·Skeletal Kinetics, Llc·20200406
• Z-2596-2020 — ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.Class II·Terminated·Skeletal Kinetics, Llc·20200406
• Z-2608-2020 — EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 813845021037 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.Class II·Terminated·Skeletal Kinetics, Llc·20200406
• Z-2609-2020 — EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 813845021020 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.Class II·Terminated·Skeletal Kinetics, Llc·20200406
• Z-2612-2020 — OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.Class II·Terminated·Skeletal Kinetics, Llc·20200406
• Z-2613-2020 — OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.Class II·Terminated·Skeletal Kinetics, Llc·20200406
• Z-2624-2020 — SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.Class II·Terminated·Skeletal Kinetics, Llc·20200406
• Z-2625-2020 — SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.Class II·Terminated·Skeletal Kinetics, Llc·20200406
• Z-2626-2020 — SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.Class II·Terminated·Skeletal Kinetics, Llc·20200406
• Z-2185-2020 — OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.Class II·Terminated·Osteomed, LLC·20200402
• Z-2186-2020 — OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.Class II·Terminated·Osteomed, LLC·20200402

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100986.