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PolyLock Plating System

by Fusion Orthopedics

510(k) K211843

PolyLock Plating System is a Class II device made by Fusion Orthopedics, cleared under FDA 510(k) K211843 on 4 Mar 2022, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211843 Date4 Mar 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HRS
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K211843

295 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K211843
UDI-DISize and differences
LapiLock TN-LL-7000-15I
FUSION ORTHOPEDICS, LLC
TN-LL-7000-15I00840124506480
Single use: yes
On the market
PolyLock Ankle AK-DT-1004
FUSION ORTHOPEDICS, LLC
AK-DT-1004 / AK-DT-100400840124515338
Single use: yes
On the market
PolyLock Ankle AK-DT-1008
FUSION ORTHOPEDICS, LLC
AK-DT-1008 / AK-DT-100800840124515352
Single use: yes
On the market
PolyLock Ankle AK-DT-1010
FUSION ORTHOPEDICS, LLC
AK-DT-1010 / AK-DT-101000840124515369
Single use: yes
On the market
PolyLock Ankle AK-DT-1512
FUSION ORTHOPEDICS, LLC
AK-DT-1512 / AK-DT-151200840124515451
Single use: yes
On the market
PolyLock Ankle AK-DT-2012
FUSION ORTHOPEDICS, LLC
AK-DT-2012 / AK-DT-201200840124515536
Single use: yes
On the market
PolyLock Ankle AK-DT-2018
FUSION ORTHOPEDICS, LLC
AK-DT-2018 / AK-DT-201800840124515567
Single use: yes
On the market
PolyLock Ankle AK-DT-2504
FUSION ORTHOPEDICS, LLC
AK-DT-2504 / AK-DT-250400840124515574
Single use: yes
On the market
PolyLock Ankle AK-DT-4503
FUSION ORTHOPEDICS, LLC
AK-DT-4503 / AK-DT-450300840124515734
Single use: yes
On the market
PolyLock Ankle TN-AK-0006
FUSION ORTHOPEDICS, LLC
TN-AK-0006 / TN-AK-000600840124520981
Single use: yes
On the market
PolyLock Ankle TN-TR-0054-A
FUSION ORTHOPEDICS, LLC
TN-TR-0054-A / TN-TR-0054-A00840124520363
Single use: no
On the market
PolyLock Ankle TN-TR-0055
FUSION ORTHOPEDICS, LLC
TN-TR-0055 / TN-TR-005500840124520929
Single use: no
On the market
PolyLock Midfoot CD-CA-1050
FUSION ORTHOPEDICS, LLC
CD-CA-1050 / CD-CA-105000840124521872
Single use: yes
On the market
PolyLock Midfoot MF-CA-1004
FUSION ORTHOPEDICS, LLC
MF-CA-1004 / MF-CA-100400840124521933
Single use: yes
On the market
PolyLock Midfoot MF-CA-1501
FUSION ORTHOPEDICS, LLC
MF-CA-1501 / MF-CA-150100840124521940
Single use: yes
On the market
PolyLock Midfoot MF-CA-2001
FUSION ORTHOPEDICS, LLC
MF-CA-2001 / MF-CA-200100840124521995
Single use: yes
On the market
PolyLock Midfoot MF-CA-2002
FUSION ORTHOPEDICS, LLC
MF-CA-2002 / MF-CA-200200840124522008
Single use: yes
On the market
PolyLock Midfoot MF-CA-2003
FUSION ORTHOPEDICS, LLC
MF-CA-2003 / MF-CA-200300840124522060
Single use: yes
On the market
PolyLock Midfoot MF-LK-2742
FUSION ORTHOPEDICS, LLC
MF-LK-2742 / MF-LK-274200840124524941
Single use: yes
On the market
PolyLock Midfoot MF-LK-2748
FUSION ORTHOPEDICS, LLC
MF-LK-2748 / MF-LK-274800840124525474
Single use: yes
On the market
PolyLock Midfoot MF-MP-2052
FUSION ORTHOPEDICS, LLC
MF-MP-2052 / MF-MP-205200840124511057
Single use: yes
On the market
PolyLock Midfoot MF-MP-2065
FUSION ORTHOPEDICS, LLC
MF-MP-2065 / MF-MP-206500840124513754
Single use: yes
On the market
PolyLock Midfoot MF-NC-1027
FUSION ORTHOPEDICS, LLC
MF-NC-1027 / MF-NC-102700840124511347
Single use: yes
On the market
PolyLock Midfoot MF-NL-2736
FUSION ORTHOPEDICS, LLC
MF-NL-2736 / MF-NL-273600840124524996
Single use: yes
On the market
PolyLock Midfoot MF-NL-2742
FUSION ORTHOPEDICS, LLC
MF-NL-2742 / MF-NL-274200840124525016
Single use: yes
On the market
PolyLock Midfoot MF-TN-1024
FUSION ORTHOPEDICS, LLC
MF-TN-1024 / MF-TN-102400840124521087
Single use: yes
On the market
PolyLock Midfoot SB-PM-0002
FUSION ORTHOPEDICS, LLC
SB-PM-0002 / SB-PM-000200840124501782
Single use: yes
On the market
PolyLock Midfoot TN-CA-2002
FUSION ORTHOPEDICS, LLC
TN-CA-2002 / TN-CA-200200840124521803
Single use: no
On the market
PolyLock Midfoot TN-MF-2016
FUSION ORTHOPEDICS, LLC
TN-MF-2016 / TN-MF-201600840124520103
Single use: no
On the market
PolyLock Midfoot TN-MF-3125
FUSION ORTHOPEDICS, LLC
TN-MF-3125 / TN-MF-312500840124519909
Single use: no
On the market
PolyLock Midfoot TN-MF-5075
FUSION ORTHOPEDICS, LLC
TN-MF-5075 / TN-MF-507500840124520219
Single use: no
On the market
PolyLock Midfoot TN-MF-7017
FUSION ORTHOPEDICS, LLC
TN-MF-7017 / TN-MF-701700840124520189
Single use: no
On the market
PolyLock Midfoot TN-MF-7050
FUSION ORTHOPEDICS, LLC
TN-MF-7050 / TN-MF-705000840124519992
Single use: no
On the market
PolyLock Midfoot TN-MF-7052-S
FUSION ORTHOPEDICS, LLC
TN-MF-7052-S / TN-MF-7052-S00840124514775
Single use: yes
On the market
PolyLock Midfoot TN-MF-7535
FUSION ORTHOPEDICS, LLC
TN-MF-7535 / TN-MF-753500840124519961
Single use: no
On the market
PolyLock Midfoot TN-MF-7575
FUSION ORTHOPEDICS, LLC
TN-MF-7575 / TN-MF-757500840124520233
Single use: no
On the market
PolyLock Midfoot TN-TR-0070
FUSION ORTHOPEDICS, LLC
TN-TR-0070 / TN-TR-007000840124520684
Single use: no
On the market
PolyLock Midfoot TN-TR-0084
FUSION ORTHOPEDICS, LLC
TN-TR-0084 / TN-TR-008400840124525115
Single use: no
On the market
PolyLock ML-FT-2516
FUSION ORTHOPEDICS, LLC
ML-FT-251600840124510050
Single use: yes
On the market
PolyLock ML-FT-2522
FUSION ORTHOPEDICS, LLC
ML-FT-252200840124510081
Single use: yes
On the market
PolyLock ML-FT-2526
FUSION ORTHOPEDICS, LLC
ML-FT-252600840124510104
Single use: yes
On the market
PolyLock ML-FT-2534
FUSION ORTHOPEDICS, LLC
ML-FT-253400840124510142
Single use: yes
On the market
PolyLock ML-FT-2536
FUSION ORTHOPEDICS, LLC
ML-FT-253600840124510166
Single use: yes
On the market
PolyLock ML-HD-2522
FUSION ORTHOPEDICS, LLC
ML-HD-252200840124509801
Single use: yes
On the market
PolyLock ML-HD-2550
FUSION ORTHOPEDICS, LLC
ML-HD-255000840124509887
Single use: yes
On the market
PolyLock ML-LK-2410
FUSION ORTHOPEDICS, LLC
ML-LK-241000840124509900
Single use: yes
On the market
PolyLock ML-LK-2426
FUSION ORTHOPEDICS, LLC
ML-LK-242600840124509986
Single use: yes
On the market
PolyLock Small Bone TN-TR-0060
FUSION ORTHOPEDICS, LLC
TN-TR-0060 / TN-TR-006000840124520752
Single use: no
On the market
PolyLock TN-SB-7000
FUSION ORTHOPEDICS, LLC
TN-SB-7000 / TN-SB-700000840124519664
Single use: no
On the market
PolyLock TN-SB-7002
FUSION ORTHOPEDICS, LLC
TN-SB-7002 / TN-SB-700200840124519718
Single use: no
On the market

Similar devices

Other devices filed under FDA product code HRS (Plate, Fixation, Bone).

Other devices from Fusion Orthopedics USA, LLC

  • FibFix FN-TH-4713-S

    Class II

  • FibFix FN-TH-4713

    Class II

  • FibFix FN-TH-5713

    Class II

  • FibFix FN-TH-5713-S

    Class II

See all devices from Fusion Orthopedics USA, LLC →