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ILIZAROV

Model 102412 · Smith & Nephew, Inc. · DI 03596010031600

JDW — Pin, Fixation, Threaded · Class II · 21 CFR 888.3040

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

4913172019-01: 0 reports for this device; peer average 1.83/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1.33/device2019-07: 0 reports for this device; peer average 1.25/device2019-08: 0 reports for this device; peer average 17/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 2.67/device2019-12: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 5/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1.8/device2020-05: 0 reports for this device; peer average 2.5/device2020-06: 0 reports for this device; peer average 2.33/device2020-07: 0 reports for this device; peer average 1.33/device2020-08: 0 reports for this device; peer average 1.5/device2020-10: 0 reports for this device; peer average 1.33/device2020-11: 0 reports for this device; peer average 2.83/device2020-12: 0 reports for this device; peer average 2.5/device2021-01: 0 reports for this device; peer average 1.5/device2021-02: 0 reports for this device; peer average 3.33/device2021-03: 0 reports for this device; peer average 6/device2021-04: 0 reports for this device; peer average 2.11/device2021-05: 0 reports for this device; peer average 12.29/device2021-06: 0 reports for this device; peer average 2.83/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1.25/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 1.5/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2.67/device2022-03: 0 reports for this device; peer average 1.75/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 1.33/device2022-06: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 2.5/device2022-08: 0 reports for this device; peer average 1.5/device2022-09: 0 reports for this device; peer average 1.67/device2022-10: 0 reports for this device; peer average 1.75/device2022-11: 0 reports for this device; peer average 3/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 1.33/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.2/device2023-04: 0 reports for this device; peer average 1.33/device2023-05: 0 reports for this device; peer average 1.5/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1.2/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 3/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.33/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1.4/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1.6/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1.5/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2.83/device2025-06: 0 reports for this device; peer average 1.33/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1.5/device2025-12: 0 reports for this device; peer average 1.25/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 1.4/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 1/device01020304050607080910111201020305060708101112010203040506070809101112010203040506070809101112010203040506070910110102030405060708091011120102060809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.83
2019-0202
2019-0301
2019-0402
2019-0502
2019-0601.33
2019-0701.25
2019-08017
2019-0901
2019-1001
2019-1102.67
2019-1203
2020-0105
2020-0202
2020-0301.8
2020-0502.5
2020-0602.33
2020-0701.33
2020-0801.5
2020-1001.33
2020-1102.83
2020-1202.5
2021-0101.5
2021-0203.33
2021-0306
2021-0402.11
2021-05012.29
2021-0602.83
2021-0702
2021-0802
2021-0901.25
2021-1002
2021-1103
2021-1201.5
2022-0102
2022-0202.67
2022-0301.75
2022-0403
2022-0501.33
2022-0603
2022-0702.5
2022-0801.5
2022-0901.67
2022-1001.75
2022-1103
2022-1202
2023-0101.33
2023-0201
2023-0301.2
2023-0401.33
2023-0501.5
2023-0601
2023-0701.2
2023-0901
2023-1001
2023-1103
2024-0101
2024-0201
2024-0301.33
2024-0402
2024-0501.4
2024-0601.5
2024-0701
2024-0801.6
2024-0901
2024-1001
2024-1101.5
2024-1202
2025-0102
2025-0202.83
2025-0601.33
2025-0801
2025-0901
2025-1002
2025-1101.5
2025-1201.25
2026-0101
2026-0202
2026-0301.4
2026-0401
2026-0501.5
2026-0601
This device (reports/month)Average device in JDW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K201253 — cites (transitively): K023134 (d1), K023921 (d1), K042312 (d1), K042436 (d1), K072212 (d1), K090926 (d1), K093047 (d1), K120871 (d1), K130479 (d1), K920024 (d1), K953397 (d1), K970713 (d1), K970751 (d1), K994143 (d1), K090675 (d2), K870961 (d2), K962808 (d2), K970748 (d2) — cited as predicate by K232838, K241563, K241769, K251128, K253291, K253613

K994143 — cited as predicate by K093047, K093753, K101338, K130479, K201253, K210953, K213874, K221792, K223112

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Smith & Nephew, Inc.

  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2014-06-11 Smith & Nephew, Inc.
  • Warning Letter 2010-09-16 Ascension Orthopedics, Inc
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  • NAI 2018-03-30 Ascension Orthopedics, Inc · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-01-30 Smith & Nephew · 0 citations
  • NAI 2017-08-21 Smith & Nephew, Inc. Advanced Surgical Devices Division · 0 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations