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Medical DevicesKONEX 25361018 approvals

RootLoc Co., Ltd.

Official website

Founded in 2014 and listed on KONEX in 2020, RootLoc manufactures artificial knee joints and spinal implants for orthopedic surgery.

As of 2026-10-10, RootLoc Co., Ltd. has 16 Korean MFDS device approvals, 2 US FDA clearances/approvals on record (counted by the MAA Company Index from its own matching of public databases).

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Business overview

Source: DART corporate disclosure

Founded 2014, listed KONEX 2020, RootLoc makes implantable orthopedic and neurosurgical devices. Core products: artificial knee joints, spinal implants, antibacterial bone cement sold since 2022, and an artificial hip joint using DHF technology licensed from Modal (US) in 2020. Its knee joint holds Korea's second FDA approval; its spinal implant business, from L&K Biomed since 2019, also acts as distributor.

Products & technology

  • Artificial knee jointImplantable device for orthopedic knee replacement surgery
  • Spinal implant (spinal fixation device)Implantable device for spinal fixation in neurosurgery
  • Antibacterial bone cementFixes artificial joints to bone and protects against bacteria-induced osteoarthritis infection
  • Artificial hip jointImplantable device for orthopedic hip replacement surgery

Regulatory approvals

data.go.kr · openFDA

16 Korean MFDS device approvals · 2016–2025 / 2 US FDA 510(k) · 2018

  • MFDSIrrigation unit, general purpose, electrically-powered2025-04-04
    Product approval · Class 2제인 25-4280 호
  • MFDSRetractor, surgical, manually-operated2025-03-28
    Product approval · Class 1제신 25-394 호
  • MFDSSurgical supplies2025-02-10
    Product approval · Class 1제신 25-136 호
  • MFDSSpinal internal fixation system, intervertebral body2021-12-02
    Product approval · Class 3제허 21-972 호
  • MFDSCement, orthopaedic, bone, antibioticRevoked2021-05-31
    Product approval · Class 4제허 21-436 호
  • MFDSIrrigation unit, general purpose, electrically-powered2019-06-28
    Product approval · Class 2제인 19-4523 호
  • MFDSOrthopaedic bone calliper2018-12-12
    Product approval · Class 1제신 18-1640 호
  • MFDSSurgical drill handpiece, manual2018-12-11
    Product approval · Class 1제신 18-1639 호
  • MFDSGuide for medical use2018-12-10
    Product approval · Class 1제신 18-1627 호
  • MFDSInstruments, bone, surgical, manually-operated2018-12-07
    Product approval · Class 1제신 18-1617 호
  • MFDSSizer for medical or dental use2018-12-04
    Product approval · Class 1제신 18-1600 호
  • MFDSPuncture instrument, surgical, manually-operated, reusable2018-12-04
    Product approval · Class 1제신 18-1599 호
Show 6 more
  • MFDSTrephine instrument, manually-operated, reusable2018-12-04
    Product approval · Class 1제신 18-1598 호
  • MFDSInstruments, bone, surgical, manually-operated2018-12-04
    Product approval · Class 1제신 18-1592 호
  • FDAAcculoc Total Knee System2018-09-27
    510(k) · SpecialOrthopedicK182370
  • FDAAcculoc Total Knee System2018-03-23
    510(k) · TraditionalOrthopedicK170753
  • MFDSKnee prosthesis, internal, total2017-07-17
    Product approval · Class 3제허 17-508 호
  • MFDSHammer, surgical, manually-operated2016-10-06
    Product approval · Class 1제신 16-1186 호

R&D and key agreements

Source: DART corporate disclosure

항균골시멘트 · 골관절염 감염 방지 · 개발 완료·식약처 품목등록·판매중 · Developed in-house, registered with Korea's MFDS, and sold since 2022

인공고관절(DHF) · 고관절 치환 · 개발중 · Development underway using DHF manufacturing technology licensed from US-based Modal for USD 580,000 in Sept 2020

척추고정기기(척추임플란트) · 척추 고정 · 개발중 · Development leveraging artificial joint know-how, building on spinal implant business acquired from L&K Biomed

Key disclosures

KRX KIND via OpenDART
Show 15 more events

Patents

KIPRIS · applicant-matched

AI reads

MAA server logs · IP-verified
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Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

Alpha AI Co.,Ltd.11 shared

Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.

Corentec Co., Ltd.10 shared

Founded in 2000 and KOSDAQ-listed in 2013, Corentec makes artificial joints; hip and knee implants exceed 85% of revenue.

L&K BIOMED CO., LTD.9 shared

Spinal implant device maker founded 2008, listed on KOSDAQ 2016; produces Cervical and Thoraco Lumbar Cage, Screw, and Plate products.

CG MedTech Co.,Ltd.9 shared

Founded in 1997 and KOSDAQ-listed in 2015, CG MedTech makes orthopedic medical devices and also operates an electric energy business.

MEDYSSEY CO.,LTD9 shared

Manufactures spinal implants and metal 3D-printed patient-specific implants, exporting to over 25 countries.

OSTEONIC Co., Ltd.9 shared

Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.

JMT CO.,Ltd.6 shared

Provides EMS and SMT manufacturing services for TFT-LCD and OLED panel driver PBAs.

CUREXO, INC.6 shared

Develops and sells surgical robots Cuvis-joint/Cuvis-spine and the rehabilitation robot Morning Walk.

Organ Eco Tech Co.,Ltd.5 shared

Organ Eco Tech, founded in 2006 and KONEX-listed in 2016, manufactures spinal implants.

CELLUMED CO., LTD.5 shared

KOSDAQ-listed holding company making medical devices and biologics including bone graft rhBMP2 and knee implant TKR.

WSI Co., Ltd.4 shared

Founded and KOSDAQ-listed in 2018, WSI distributes spine/joint devices and has expanded into medical robots and pharma via subsidiaries.

YUHAN CORPORATION4 shared

Founded in 1926 and listed on the KOSPI in 1962, Yuhan Corporation is a comprehensive pharmaceutical company known for its innovative drug Leclaza.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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