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Model 71461017 · Smith & Nephew, Inc. · DI 03596010544247

KRR — Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3540

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.

12352019-01: 0 reports for this device; peer average 1.8/device2019-02: 0 reports for this device; peer average 1.5/device2019-03: 0 reports for this device; peer average 1.5/device2019-04: 0 reports for this device; peer average 1.57/device2019-05: 0 reports for this device; peer average 1.5/device2019-06: 0 reports for this device; peer average 1.8/device2019-07: 0 reports for this device; peer average 1.43/device2019-08: 0 reports for this device; peer average 1.5/device2019-09: 0 reports for this device; peer average 1.56/device2019-10: 0 reports for this device; peer average 1.77/device2019-11: 0 reports for this device; peer average 1.17/device2019-12: 0 reports for this device; peer average 1.67/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 3/device2020-03: 0 reports for this device; peer average 2.7/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2.67/device2020-07: 0 reports for this device; peer average 3.75/device2020-08: 0 reports for this device; peer average 2.73/device2020-09: 0 reports for this device; peer average 1.67/device2020-10: 0 reports for this device; peer average 1.67/device2020-11: 0 reports for this device; peer average 3.11/device2020-12: 0 reports for this device; peer average 1.75/device2021-01: 0 reports for this device; peer average 1.86/device2021-03: 0 reports for this device; peer average 1.86/device2021-04: 0 reports for this device; peer average 1.67/device2021-05: 0 reports for this device; peer average 1.75/device2021-06: 0 reports for this device; peer average 3.33/device2021-07: 0 reports for this device; peer average 1.5/device2021-08: 0 reports for this device; peer average 2.5/device2021-09: 0 reports for this device; peer average 2.33/device2021-10: 0 reports for this device; peer average 2.5/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2.14/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1.5/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 4/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 2.75/device2022-09: 0 reports for this device; peer average 1.5/device2022-10: 0 reports for this device; peer average 2.5/device2022-11: 0 reports for this device; peer average 1.8/device2023-01: 0 reports for this device; peer average 4.5/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 2.67/device2023-08: 0 reports for this device; peer average 1.67/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 2.71/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 1.67/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1.75/device2024-10: 0 reports for this device; peer average 1.83/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 1.5/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 1.6/device2025-03: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1.5/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 2.22/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 1.67/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 2/device0102030405060708091011120102030405060708091011120103040506070809101112010203040506070809101101020304050607081011120102030405060809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.8
2019-0201.5
2019-0301.5
2019-0401.57
2019-0501.5
2019-0601.8
2019-0701.43
2019-0801.5
2019-0901.56
2019-1001.77
2019-1101.17
2019-1201.67
2020-0101
2020-0203
2020-0302.7
2020-0401
2020-0501
2020-0602.67
2020-0703.75
2020-0802.73
2020-0901.67
2020-1001.67
2020-1103.11
2020-1201.75
2021-0101.86
2021-0301.86
2021-0401.67
2021-0501.75
2021-0603.33
2021-0701.5
2021-0802.5
2021-0902.33
2021-1002.5
2021-1102
2021-1202
2022-0102
2022-0202.14
2022-0301
2022-0401.5
2022-0501
2022-0604
2022-0701
2022-0802.75
2022-0901.5
2022-1002.5
2022-1101.8
2023-0104.5
2023-0203
2023-0302
2023-0401
2023-0503
2023-0602
2023-0702.67
2023-0801.67
2023-1002
2023-1102.71
2023-1201
2024-0102
2024-0202
2024-0301.67
2024-0402
2024-0502
2024-0602
2024-0801
2024-0901.75
2024-1001.83
2024-1102
2024-1201.5
2025-0102
2025-0201.6
2025-0301.5
2025-0402
2025-0502
2025-0602
2025-0701.5
2025-0801.5
2025-0901.67
2025-1002
2025-1102.22
2025-1202
2026-0101
2026-0201.5
2026-0302
2026-0401.67
2026-0501.5
2026-0602
This device (reports/month)Average device in KRR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K051086 — cited as predicate by K113038, K150241, K230653

K230653 — cites (transitively): K030301 (d1), K033363 (d1), K041106 (d1), K042515 (d1), K043440 (d1), K051086 (d1), K060742 (d1), K061011 (d1), K061779 (d1), K071071 (d1), K072531 (d1), K073175 (d1), K073325 (d1), K081111 (d1), K091543 (d1), K100897 (d1), K102069 (d1), K111711 (d1), K112941 (d1), K113482 (d1), K121443 (d1), K122529 (d1), K140555 (d1), K142807 (d1), K151118 (d1), K152315 (d1), K152726 (d1), K162775 (d1), K170648 (d1), K180334 (d1), K190085 (d1), K190439 (d1), K211221 (d1), K912735 (d1), K030623 (d2), K032683 (d2), K032295 (d2), K951987 (d2), K093746 (d2), K962557 (d2), K022204 (d2), K051229 (d2), K946236 (d2), K101499 (d2), K100048 (d2), K120370 (d2), K081351 (d2), K141471 (d2), K041825 (d2), K160738 (d2), K052567 (d2), K133811 (d2), K142066 (d2), K132624 (d2), K181366 (d2), K953274 (d2), K070364 (d3), K070399 (d3), K073102 (d3), K080528 (d3), K090103 (d3), K023211 (d3), K040267 (d3), K062654 (d3), K103662 (d3), K031729 (d3), K042883 (d3), K042993 (d3), K051146 (d3), K051380 (d3), K051977 (d3), K053514 (d3), K061521 (d3), K072221 (d3), K072575 (d3), K123166 (d3), K123486 (d3), K033810 (d3), K082172 (d3), K090763 (d3), K112802 (d3), K133039 (d3), K904448 (d3), K082014 (d3), K113285 (d3), K120869 (d3), K131276 (d3), K133328 (d3), K072121 (d3), K110135 (d3), K150522 (d3), K150790 (d3), K101229 (d4), K070278 (d4), K083116 (d4), K010170 (d4), K041906 (d4), K042842 (d4), K052792 (d4), K070369 (d4), K094035 (d4), K102487 (d4), K082262 (d4), K090507 (d4), K103382 (d4), K073470 (d4), K050539 (d4), K063423 (d4), K974556 (d4), K072160 (d4), K072253 (d4), P950002 (d4), K030555 (d4), K101336 (d4), K103233 (d4), K110555 (d4), K121874 (d4), K140669 (d4), K974558 (d4), K991990 (d4), K002747 (d4), K022902 (d4), K050937 (d4), K060630 (d4), K070756 (d4), K113848 (d4), K962541 (d4), K032396 (d5), K050327 (d5), K051588 (d5), K071535 (d5), K083762 (d5), K935484 (d5), K950827 (d5), K970501 (d5), K091508 (d5), K093846 (d5), K042037 (d5), K062995 (d5), K072020 (d5), K093644 (d5), K071795 (d5), K082252 (d5), K093242 (d5), K042051 (d5), K061253 (d5), K092386 (d5), K093235 (d5), K052996 (d5), K102975 (d5), K122770 (d5), K122798 (d5), K002379 (d6), K070479 (d6), K070592 (d6) — cited as predicate by K241260

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
  • NAI 2025-01-27 Integrity Orthopaedics Inc · 0 citations
  • NAI 2023-05-03 CARTIHEAL, LTD · 0 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • VAI 2020-02-06 Blue Belt Technologies, Inc · 6 citations
  • NAI 2019-10-25 Tusker Medical, Inc. · 0 citations
  • VAI 2019-10-08 Tusker Medical, Inc. · 3 citations
  • 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