510(k) Report

510(k) · Cleared

Cleared

Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate

K031183510(k) TraditionalCleared Jul 14, 200390-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Centerpulse Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jul 14, 2003 after a 90-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.

Decided
Jul 14, 2003
Review
90 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
0

14 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2018: 2 descendants cleared2010: 2 descendants cleared2019: 2 descendants cleared2013: 1 descendant cleared2021: 3 descendants cleared2025: 2 descendants cleared2015: 1 descendant cleared2017: 1 descendant cleared200020052010201520202025
  1. This deviceK031183 Tibial Spacer for the Natural-Knee II Cemented Modular Tibial…Centerpulse Orthopedics, Inc. · 2003
  2. Descendant · cites it directly · 7 of its ownK094017 Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138…Omni Life Science, Inc. · 2010 · Recalled
  3. Descendant · 2 generations on · 6 of its ownK101994 Apex Knee Modular Tibia SystemOmnlife Science · 2010 · Recalled
  4. Descendant · cites it directly · 5 of its ownK173057 Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · Recalled
  5. Descendant · 3 generations on · 5 of its ownK131472 Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013
  6. Descendant · 2 generations on · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2010: 22013: 12015: 12017: 12018: 22019: 22021: 32025: 2
2010high 3 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 14 · See all
  • K094017Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158Omni Life Science, Inc. · 2010 · cites it directly7descendants
  • K101994Apex Knee Modular Tibia SystemOmnlife Science · 2010 · 2 generations on6descendants
  • K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018 · cites it directly5descendants
  • K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013 · 3 generations on5descendants
  • K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031183Tibial Spacer for the Natural-Knee II Cemented Modular Tibial BaseplateCenterpulse Orthopedics, Inc.2003—
+1K094017Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158Omni Life Science, Inc.20106
+2K101994Apex Knee Modular Tibia SystemOmnlife Science20101
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.20182
+3K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.2013—
+2K181947Persona Revision Knee SystemZimmer, Inc.20181

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201310
201510
201710
201820
201920
202130
202520
FIG. 1 — Lineage of K031183, 2003–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JWH device

  1. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Centerpulse Orthopedics Natural-Knee System Tibial Spacer
Named without a submission number
—

What descends from it? (14)

See all 14

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K094017Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158Omni Life Science, Inc.20107
K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.20185

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K094017 (Omni Life Science, Inc., 2010) has gone furthest, with 7 descendants of its own.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

The tibial spacer is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:

Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); e.g., avascular necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g., rheumatoid arthritis;

Correctable valgus-varus deformity and moderate flexion contracture.

Those patients with failed previous surgery where pain, deformity, or dysfunction persists.

Indications for use as stated in the FDA summary.

More from Centerpulse Orthopedics, Inc.

10 FDA decisions under this applicant name. See the company

  • K033943Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 2004
  • K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc. · 20042 recalls
  • K040947Durasul BipolarCenterpulse Orthopedics, Inc. · 2004
  • K033810Natural-Knee II Unicompartmental Knee SystemCenterpulse Orthopedics, Inc. · 20041 recall
  • K033664Modification to Alloclassic Zweymuller SL Offset Femoral StemCenterpulse Orthopedics, Inc. · 20031 recall

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K031183 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031183: Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031183

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026